everlinQ endoAVF System (TVA Medical) is now approved by the US Food and Drug Administration for de novo marketing. This innovative, minimally invasive technology uses magnetic catheters and radiofrequency energy to create an arteriovenous fistula (AVF) for haemodialysis access...
The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance on abdominal aortic aneurysm (AAA) diagnosis and management. The most notable recommendation within the guideline is related to repairing unruptured aneurysms where the guideline states...
Major adverse events in patients undergoing transcarotid artery revascularisation (TCAR) were similar to those receiving a carotid endarterectomy, a study has found, despite the higher medical risk in the former group. Marc Schermerhorn (Beth Israel Deaconess Medical Center, Boston,...
Terumo has announced that it acquired CE mark for the Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease. With a September launch planned in Europe, Terumo is expected to be the first Japanese...
Veryan Medical has announced completion of enrolment of the 500th patient in the MIMICS-3D pan-European registry, a prospective, multicentre, observational registry to evaluate the BioMimics 3D Self-Expanding Stent System in the treatment of femoropopliteal artery disease. The Registry is evaluating...
Humacyte, an innovator in biotechnology and regenerative medicine, has announced that Jeffrey Lawson has been appointed president and chief executive officer. The former chairman and chief executive officer, Carrie S Cox, has assumed the role of executive chairman. Lawson, an...
George Chrysant gives an overview of combined revascularisation interventions for coronary and carotid disease, arguing that "carotid artery stenting and coronary artery bypass grafting as a combination appears to be significantly safer and associated with better outcomes." Atherosclerosis affects multiple...
Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat long superficial femoral artery lesions in patients with peripheral artery disease. "As superficial femoral artery disease...
The US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has provided a favourable recommendation on the premarket approval application for INCRAFT AAA Stent Graft System (Cardinal Health). The panel voted 11...
Fresenius Medical Care, the world's largest provider of dialysis products and services, and Humacyte, Inc., a medical research, discovery and development company, have announced a strategic, global partnership and a US$150 million equity investment. This agreement has the potential to...
In this supplement: Assessing the needs of peripheral arterial disease and critical limb ischaemia The role of Philips solutions in solving needs: Highlighting tools and devices Perfusion angiography with the 2D Perfusion software Patient cases Read or download the educational...
In this article, Bijan Modarai outlines recent research on the effects of radiation exposure in high-volume interventionalists, why a future with alternative modalities to X-ray guided procedures is an exciting prospect, and what safety measures could make a difference...
A new study suggests that the familial risk of abdominal aortic aneurysm is much higher than previously thought and this excess risk is highest both in female relatives and in relatives (of any sex) of female patients. According to...
Countries in the European Union have long been the first to receive new innovations in medical technology, as the EU’s Medical Device Directive (MDD) provided quicker routes to implementation of new devices than its equivalent in the USA, the...
MicroStent (Micro Medical Solutions), a vascular stent designed to reduce below-the-knee amputations caused by critical limb ischaemia (CLI) resulting from peripheral arterial disease (PAD) has been implanted for the first time in the USA. The company received approval from...
Sanford Health and Freudenberg Medical, a global developer and manufacturer for the medical device industry, have entered into a joint research and development agreement to create a device to treat blood clots and blockages within blood vessels. According to a...
A recent healthcare analysis shows that a novel, catheter-based endovascular system for creating haemodialysis access offers quality-of-life benefits and cost savings compared to the traditional surgical approach in end-stage renal disease patients. The retrospective analysis comparing the everlinQ endoAVF System...
Piotr Musiałek, from the Department of Cardiac and Vascular Diseases, John Paul II Hospital, Kraków, Poland, presented the expanded 24-month follow-up results from the PARADIGM-Extend Clinical Study utilising CGuard EPS (InspireMD) at EuroPCR 2018 (22–25 May, Paris, France). PARADIGM-Extend is...
Avinger has announced that the company received 510(k) clearance from the US Food & Drug Administration (FDA) for its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral arterial disease (PAD). Lumivascular...
Medtronic has announced first-ever-data from the SPYRAL HTN-ON MED Study. Initial study results found statistically significant and clinically important blood pressure reductions in hypertensive patients prescribed anti-hypertension medications treated with the Symplicity Spyral renal denervation (RDN) system with no...
Institut Jantung Negara (IJN; Kuala Lumpur, Malaysia) has become the first hospital in Asia to perform peripheral vascular intervention (PVI) using VascuFlex Multi-LOC (B Braun), a multiple stent delivery system designed for the treatment of peripheral arterial disease (PAD). The procedure...
Med Alliance SA, a company developing and commercialising the first sirolimus micro-reservoir drug-coated balloon (SELUTION DCB) to treat patients suffering from peripheral artery disease (PAD), coronary artery disease (CAD), arteriovenous fistulas (AVF) and grafts (AVG) for end-stage renal disease,...
Marc Schermerhorn (Boston, USA) discusses the three-year results of an analysis on the long-term survival of Nellix EVAS system (Endologix) IDE trial patients vs. a cohort of EVAR patients. The study found that EVAS is associated with higher long-term...
Surmodics, a provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has reached an agreement with Embolitech to acquire an innovative thrombectomy platform technology and related intellectual property with broad potential peripheral vascular...
Endospan, a company developing off-the-shelf endovascular repair of Aortic Arch Disease including aneurysms and dissections, has announced that it has elected Jeff Elkins to its board of directors. Elkins has been president and CEO of Veniti since July 2015. Previously, Elkins was COO and...
The first 24-month data from the LUTONIX AV investigational device exemption trial were presented at Charing Cross yesterday. These interim data show a sustained effectiveness benefit for the Lutonix drug-coated balloon (BD) and indicate that it leads to an...
At the Charing Cross Symposium (CX; 24–27 April, London, UK) delegates heard compelling research-in-progress from a multidisciplinary team of surgeons, statisticians and health economists that the initial aortic diameter plus annual secondary sac diameter, as measured by ultrasound close...
Laerdal Medical has announced the launch of their new simulation training technology, SimMan Vascular. The company has partnered with endovascular simulator developer Mentice to produce the SimMan Vascular system, which was introduced at the Simulation User Network conference (SUN;...
The BATTLE trial comparing a drug-eluting stent (Zilver PTX, Cook Medical) vs. a bare metal stent (Misago, Terumo) for the treatment of intermediate femoropopliteal lesions has failed to the show superiority of the paclitaxel-coated stent at one-year follow-up. The...
In an exciting session at the Charing Cross Symposium (CX; 24-27 April, London, UK), the audience witnessed the demonstration of a novel treatment strategy with intravascular lithotripsy for calcified arterial stenosis. It will now become a CX tradition to...
Stroke is a major concern following TEVAR (thoracic endovascular aortic repair) and Charing Cross delegates heard the results from a collaborative study that pooled practice data from a number of high-volume centres in order to benefit patients undergoing the...
The first two patients have been successfully enrolled in the RelayBranch Early Feasibility Study. This trial will assess the safety and efficacy of the RelayBranch Thoracic Stent-Graft system (Terumo Aortic) in patients with thoracic aortic pathologies requiring treatment proximal...
Ulf Teichgräber, Jena, Germany, discusses the EffPAC trial 12-month results which were presented for the first time at CX 2018
Terumo Aortic have announced the European limited market release of the RelayPro thoracic stent graft system at the 2018 Charing Cross Symposium (CX; 24–27 April, London, UK). RelayPro is a low profile, next generation device designed to expand the...
Medtronic has announced that it has received US Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD). Approval was...
Vascutek and Bolton Medical, subsidiaries of Terumo Corporation of Japan, have combined into Terumo Aortic. Combining the aortic companies into a single business, Terumo looks to grow its presence in the global aortic and vascular implants market. The new company...
LimFlow, a developer of peripheral endovascular technology focused on the treatment of critical limb ischemia (CLI), has announced it has secured €27 million (US$33.5 million) in an oversubscribed Series C financing. Proceeds from the Series C financing will fund the...
Colin Bicknell (Imperial College, London, UK) speaks to Vascular News about his experience of using EndoAnchors in thoracic endovascular aortic repair (TEVAR), sharing his tips and techniques.
Intact Vascular, a developer of medical devices for minimally invasive peripheral vascular procedures, has announced that it closed a Series C financing totaling US$20 million. This financing is designed to fund the company through premarket approval (PMA) of the Tack...
Interrad Medical has announced the selection of their SecurAcath Subcutaneous Catheter Securement Device for the Innovation and Technology Payment programme by the UK National Health Service (NHS) England. The Innovation and Technology Payment (ITP) programme is designed to remove significant barriers to...
Abbott has gained FDA approval for its Perclose Proglide suture-mediated closure system. The device is designed to close access sites created by large bore catheters, stopping the blood flow.  The ProGlide is used after the insertion of large bore catheters...
This article is an advertorial by Veryan Medical. Authors: PA Gaines, T Sullivan, G Ansel, C Caro Introduction Medical advances in the treatment of femoropopliteal artery disease over the last decade reflect the on-going fight to maintain patency; and that battle is...
Cook Medical has announced that physicians in the US and Canada are once again able to order the company's Beacon Tip Torcon NB Advantage 5F catheter, used in angiographic procedures. In 2015 and 2016, Cook recalled all Beacon Tip...
SoundBite Medical Solutions has announced it has received CE marking for the SoundBite Crossing System, a novel first-in-class wire-based technology that is intended for the treatment or peripheral chronic total occlusions (CTOs) in a simpler and clinically efficient method.  “We...
The handheld medical imaging system HyperView (HyperMed Imaging) has received CE mark, allowing for distribution in Europe. The system is designed to detect perfusion of superficial tissue in support of wound care. The HyperView System is a fast, handheld, battery...
Drug-coated balloon (DCB) angioplasty devices have been categorised by the US Centers for Medicare and Medicaid Services (CMS) into the same billing code as plain balloon angioplasty, following the expiration of the technology’s transitional pass-through and new technology add-on...
Maria Antonella Ruffino spoke to Vascular News at LINC 2018 about the differences between mesh-covered stents and conventional devices in treatment of carotid artery disease, as well as the differences between currently available mesh-covered stents.
The TOBA BTK (Tack Optimized Balloon Angioplasty Below the Knee) clinical trial results have recently been published in Catheterization and Cardiovascular Intervention. The multicentre pilot study focused on collecting data supporting the safety and performance of the Tack Endovascular...
The first results have been announced from ENCORE, a pooled, global analysis of several prospective clinical trials and registries studying polymer endovascular aneurysm repair (Polymer EVAR) using Ovation Abdominal Stent Graft Systems (Endologix). ENCORE is a pooled, retrospective analysis of...
The 3,000th E-xtra Design Engineering vascular implant (Jotec/CryoLife) was recently inserted successfully. The endovascular implantation was performed at Cologne University’s academic teaching hospital, Porz am Rhein hospital, Cologne, Germany, by senior consultant Thomas May and senior physician Dr Guido...
Results and data on vascular embolic device GPX (Fluidx Medical Technology), a new proprietary in situ setting embolic agent that combines the benefits of coils, gel-beads, and other embolics, were presented at the 2018 Society of Interventional Radiology conference (17-22 March, Los...
The Horizon stent graft system, developed to treat abdominal aortic aneurysms, has received CE mark. The stent graft system is produced by Endospan, a company specialising in off-the-shelf endovascular aortic repair (EVAR). “Horizon is a unique platform that can be used...
The first patients have been enrolled in a prospective, multicentre, non-randomised study intended to evaluate the ability of the Reflow Wingman Catheter (Reflow Medical) to cross chronic total occlusions (CTOs) in peripheral lesions. Initial patient enrolments were performed by Nilesh...
Data presented at American College of Cardiology 2018 Scientific Sessions (ACC; 10–12 March, Orlando, USA) indicate that a novel multi-protein, artificial intelligence (AI)-driven test accurately diagnoses aortic stenosis—a condition with a 50% mortality-rate when left untreated. The HART AS...
Highlights: CX celebrates 40 Years of Looking Forward CX peripheral arterial controversies The future of EVAR and abdominal aortic controversies CX Aortic Workshop CX Venous Controversies CX Innovation Showcase programme highlights Summary of Vascular News profiles 2017/18 https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2018/03/VN-CX18_lowres_US.pdf
Highlights: CX celebrates 40 Years of Looking Forward CX peripheral arterial controversies The future of EVAR and abdominal aortic controversies CX Aortic Workshop CX Venous Controversies CX Innovation Showcase programme highlights Summary of Vascular News profiles 2017/18 https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2018/03/VN-CX18_low-res_EU.pdf
The second patent for peripheral artery disease-focused device company XableCath has been granted in the USA. The new patent specifically describes a catheter that controls tissue contact and has a rigid ring implement that opens a blood vessel occlusion by...
Medical technology company Bentley, a developer and manufacturer of devices for the minimally invasive treatment of vascular diseases, has announced that it will officially open its new headquarters on 21 April 2018. The move to the state-of-the-art facilities, also...
The 24-month data from the Viabahn BX Flex balloon-expandable stent (Gore) investigational device exemption (IDE) trial are “promising” with sustained clinical and patency benefits and a favourable safety profile consistent with the previously published nine-month outcomes. These results were presented...
Preliminary findings from an initial study with 25 patients have shown that measuring the changes in oxygen concentration at baseline, during, and after endovascular revascularisation, can predict wound healing and functional improvement in critical limb ischaemia patients. Marianne Brodmann, Medical...
Andrew Holden spoke to Vascular News at LINC 2018 (Leipzig Interventional Course; 30 January–2 February, Leipzig, Germany) about the new data from the IN.PACT AV access trial and its significance, as well as Holden's experience with the drug-coated balloon...
Contego Medical has announced the beginning of enrolment in the PERFORMANCE I trial, a clinical trial designed to evaluate the safety and feasibility of the Neuroguard IEP carotid stent and post-dilation balloon system, with integrated embolic protection. The Neuroguard IEP...
Cardiovascular Systems Inc (CSI) presented 18-month outcomes from its LIBERTY 360 study at the Cardiovascular Research Technologies (CRT; 3-6 March, Washington, DC, USA). The study evaluates the acute and long-term clinical and economic outcomes of endovascular device interventions, including...
The first patient has been treated in the EVAS2 IDE confirmatory clinical study of the investigational Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix) by Sajjad M Hussain,  chief of the Department of Vascular Surgery at St Vincent Health and...
Terumo has entered into a definitive asset purchase agreement with Medeon Biodesign for its XPro large bore vascular closure system. The transaction consists of an up-front payment of US$20 million and milestone payments. According to a press release, Medeon will continue to provide...
New two-year results from the IN.PACT SFA Japan trial were presented at the Leipzig Interventional Course (LINC; 30 January–2 February, Leipzig, Germany) by Osamu Iida, Kansai Rosai Hospital, Hyogo, Japan. The results were consistent with two-year findings from the...
The BioMimics 3D (Veryan Medical) helical swirling flow stent system provides an alternative to antiproliferative drugs, according to one-year data from the MIMICS-2 trial. The results were presented at Leipzig Interventional Course (LINC; 30 January–2 February 2018, Leipzig, Germany)...
Abbott and Surmodics have announced an agreement whereby Abbott will have exclusive worldwide commercialisation rights for Surmodics' SurVeil drug-coated balloon (DCB) to treat the superficial femoral artery, which is currently being evaluated in a US pivotal clinical trial. Separately, Abbott...
Access Vascular has announced that the company received 510(k) clearance from the US Food and Drug Administration (FDA) for its lead product, the HydroPICC, a peripherally inserted central catheter (PICC), intended for long-term use. In pre-clinical testing, the HydroPICC...
CBSET, a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies, has announced that its scientists have published data and analyses “Defining drug and target protein distributions after stent-based drug release: Durable versus deployable...
Vascular News interviews Panos Kitrou, Patras University Hospital, Rio, Greece, on the interim data from the LUTONIX DCB AV registry trial. The data were presented at the Leipzig Interventional Course 2018 (LINC; 30 January-2 February, Leipzig, Germany). https://www.youtube.com/watch?v=g1xN3knVdw4  
Endologix, a California-based developer and marketer of innovative treatments for aortic disorders, has announced that John McDermott is stepping down as the company’s Chief Executive Officer (CEO). McDermott will remain in his current role until a successor is found. "His...
PQ Bypass has announced the enrolment of the first patients in the pivotal DETOUR II trial in the USA. The trial is a prospective, single-arm clinical trial designed to evaluate the DETOUR System for percutaneous femoropopliteal bypass. The study will...
Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular interventions. The system brings the added benefits of robotic precision and radiation protection to minimally invasive...
The Food and Drug Administration (FDA) has today issued the final rule on “human subject protection; acceptance of data from clinical investigations for medical devices”. The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted...

Michael Edmonds

Michael Edmonds is professor of Diabetic Foot Medicine, King’s College London, and consultant physician, King’s College Hospital, London, UK. A pioneer in many areas of the diabetic foot, Edmonds speaks about his interest in diabetes and its treatment, the...
Data from the LOCOMOTIVE registry first-in-man trial investigating the VascuFlex Multi-Loc, B Braun’s multiple stent delivery system, were presented by Klaus Amendt (Diakonissenkrankenhaus, Mannheim, Germany) at the Leipzig Interventional Course (LINC; 30 January­–2 February 2018, Leipzig, Germany). The data...
After two years of follow-up, the ILLUMENATE Global study has confirmed the durability of the Stellarex drug-coated balloon (Spectranetics/Philips) with primary patency rates comparable to those reported in randomised controlled trials. The data were presented by principal investigator Thomas Zeller...
Cardiovascular Systems, a medical device company developing and commercialising  interventional treatment systems for peripheral and coronary artery disease, announced today that the first patients were treated using its FDA-cleared extended length Diamondback 360 peripheral orbital atherectomy device (OAD) to treat peripheral artery...
This educational supplement is for distribution within Europe only. In this supplement: The rationale of directional atherectomy and DCB angioplasty for the treatment of “no-stent zones” CASE #1: Popliteal and tibial artery occlusions CASE #2: Severe and calcified CFA disease CASE #3: Long...
Tokyo-based Terumo Corporation has announced an investment of £33 million in one of its subsidiary companies, Vascutek Limited, located near Glasgow, UK. According to a company release, the investment has been approved for the major expansion of Vascutek’s headquarters and...
Cagent Vascular, a developer of technology for vessel dilatation in cardiovascular interventions, has announced positive results from the first-in-human PRELUDE study of the company's percutaneous transluminal angioplasty (PTA) balloon catheter. Principal invesitagor Andrew Holden (Auckland, New Zealand) presented 30-day and...
Early data from the first randomised controlled trial to compare two drug-coated balloons (DCBs) suggest that the primary patency obtained with the Ranger DCB (Boston Scientific) is “comparable” to that achieved with the IN.PACT DCB (Medtronic) in the treatment...
Highlights: COMPASS PAD signals new direction in anticoagulation of peripheral arterial disease patients Gutterless chimney endograft could be the “pot of gold at the end of the rainbow” Ross Naylor: ESVS carotid guidelines Profile: Michael Edmonds https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2018/02/77-Vascular-News_US.pdf
Highlights: COMPASS PAD signals new direction in anticoagulation of peripheral arterial disease patients Gutterless chimney endograft could be the “pot of gold at the end of the rainbow” Ross Naylor: ESVS carotid guidelines Profile: Michael Edmonds https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2018/02/77-Vascular-News_EU.pdf
Endologix, a developer and marketer of treatments for aortic disorders, has announced the completion of enrollment in the ELEVATE (Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft) IDE clinical study. The objective of the 75-patient study is to...
An international meta-analysis of clinical experience in patients who received an endovascular arteriovenous fistula (endoAVF) for haemodialysis access was presented at Leipzig Interventional Course (LINC; 30 January–2 February, Leipzig, Germany) 2018. The meta-analysis, which analysed data from 236 patients...
Primary endpoint data from the first-in-man study of SELUTION, Med Alliance’s novel sirolimus-coated balloon, were presented at the Leipzig Interventional Course (LINC; 29 January–2 February, Leipzig, Germany) by principal investigator Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany. Median late lumen loss...
LimFlow has announced completion of enrolment of the original 10-patient cohort in the US feasibility study of the LimFlow percutaneous deep vein arterialisation system. The company also announced that the US FDA has accepted the company’s proposal to expand...
Medtronic added to its body of clinical evidence supporting the IN.PACT Admiral drug-coated balloon with new presentations that demonstrated durable and consistent clinical outcomes in peripheral artery disease. The new data presented at the Leipzig Interventional Course (LINC) in...
Bentley has launched BeGraft Plus, a covered balloon expandable stent indicated for restoring and improving the patency and treatment of aneurysms, acute perforations and ruptures of the iliac and renal arteries in the European markets. Eric Verhoeven (Nuremberg, Germany) officially...
Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS-2, a prospective, single arm, multicentre clinical study to evaluate the safety and effectiveness of the BioMimics 3D helical, swirling flow stent system in the treatment of patients with...
The post-market, non-interventional, multicentre, non-randomised, single-arm study will enroll approximately 150 patients across 25 sites in Europe and Russia, and will evaluate the safety and performance of a ChEVAR procedure using the Endurant II/IIs stent graft system (Medtronic) in...
Medtronic has announced the launch of the ENCHANT (Endurant ChEVAR New Indication Trial) study. The post-market, non-interventional, multi-centre, non-randomised, single-arm study will enrol approximately 150 patients across 25 sites in Europe and Russia, and will evaluate the safety and...
The final results of the ENDURE study, investigating the efficacy of the Chocolate Touch drug-coated balloon (QT Vascular), show “promising evidence of the drug effect by way of low late lumen loss and high patency at 12 months,” according...
  Bluegrass Vascular Technologies has announced the enrolment of its first patients in the SAVE-US (Surfacer System to Facilitate Access in Venous Occlusions–United States) pivotal trial. The SAVE-US trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Surfacer Inside-Out Access...
Enrolment is complete in the Lutonix below-the-knee trial with BD planning to submit a pre-market approval application to the US Food and Drug Administration (FDA) in late 2018. The Lutonix below-the-knee trial is a prospective, multicentre, randomised, controlled trial intended...
The first patients have been enrolled in the US FDA pivotal study of VasQ (Laminate Medical Technologies), an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for haemodialysis. The first surgeries were performed by...
Cardiovascular Systems (CSI) has announced two new partnerships broadening the company’s product portfolio. According to a company release, CSI is now the exclusive US distributor of OrbusNeich balloon products. Additionally, the company has signed an original equipment manufacturer agreement...
A new study suggests thoracic endovascular aortic repair (TEVAR) may be appropriate in uncomplicated Type B aortic dissection (TBAD) based on several anatomic criteria determined by CT imaging. Historically, the standard of care for uncomplicated patients with TBAD has been...
The registry will combine noninvasive, vascular ultrasound testing data with vascular treatment and outcomes data, making it possible to analyse the relationships between diagnosis and care provided to patients with vascular disease. The Society for Vascular Ultrasound (SVU), the Society...
There has been significant progress in limb salvage in patients with peripheral artery disease (PAD) and critical limb ischaemia (CLI) over the past two decades. These advancements have been promoted by the increased knowledge and understanding of the disease...
XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the US Food and Drug Administration (FDA). The blunt tip catheter facilitates true lumen passage of lesions, both above and below...
BD, a leading global medical technology company, has announced it has completed the acquisition of C R Bard, creating a new health care industry leader with approximately US$16 billion in annualised revenue. In a press release, BD state that the combined...
Endovascular navigation startup Centerline Biomedical has successfully completed a fifth preclinical study at Cleveland Clinic facilities evaluating its surgical navigation system, the Intra-Operative Positioning System (IOPS). The study was the company’s most noteworthy study to date; demonstrating ability to...
Global healthcare company Penumbra has entered into a joint venture with virtual reality (VR) company Sixense Enterprises, for the purpose of exploring healthcare applications of the technology. MVI Health represents a unique partnership that brings together Sixense Enterprises, a team with deep...
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The device was used by vascular surgeon Arne Schwindt to treat patients at St Franziskus Hospital in Münster, Germany. Schwindt,...
Stephan Haulon

Stéphan Haulon

Growing up in Kenya, Stéphan Haulon’s early experience of the medical profession came in the form of the “flying doctors”, who piloted small planes to remote areas to care for patients. Combined with his post-medical school experience providing humanitarian...
Fenestrated or branched endovascular aneurysm repair (F/BEVAR) for thoracoabdominal or complex aortic aneurysm patients “is not cost-effective at two years” compared with open repair, particularly for patients with para/juxtarenal abdominal aortic aneurysms and infradiaphragmatic thoracoabdominal aortic aneurysms. “F/BEVAR have shown...
ReCor Medical announced today randomisation of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study. RADIANCE-HTN, ReCor's study of its Paradise renal denervation system in people with hypertension, involves two study cohorts: "SOLO", whose subjects are...
Gore has announced the first implant of the Gore Excluder Conformable abdominal aortic aneurysms (AAA) endoprosthesis in the USA. The procedure took place on 19 December, 2017 at Maimonides Medical Center in New York, USA by Robert Rhee, chief...

Teleflex gets new CEO

Teleflex has announced that it has completed its previously announced senior leadership transition with Liam Kelly succeeding Benson Smith as president and chief executive officer effective 1 January 2018. Kelly previously served as Teleflex’s president and chief operating officer. Smith,...
PQ Bypass has received conditional approval of its investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate the pivotal DETOUR II clinical trial. As the first-ever pivotal trial for percutaneous femoropopliteal bypass, DETOUR II...
Janssen has submitted a supplemental new drug application to the US Food and Drug Administration (FDA) for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in...
The use of surgical simulators is important to assess competence, plan complex cases and develop skills, but they “do not replace clinical and surgical experience,” according to José Fernandes e Fernandes (Lisbon Academic Medical Centre and Lisbon Cardiovascular Institute,...
Following a fenestrated endovascular aneurysm repair (FEVAR), the infrarenal aortic neck often continues to dilate. At the 2017 VEITHsymposium, Benjamin Starnes (University of Washington, Seattle, USA) suggested that such dilation is harmful when observed in standard EVAR practised outside...
Drug-eluting technologies, such as balloons coated with paclitaxel (DCB), are now the gold standard treatment for patients presenting with symptomatic peripheral artery disease (PAD) in the femoropopliteal region. DCBs have shown better clinical outcomes against uncoated balloons (PTA) for the treatment of femoropopliteal...
CryoLife, Inc, a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has completed its previously announced acquisition of Jotec AG, a German-based, privately-held developer of technologically differentiated endovascular stent grafts,...
InspireMD has announced it has signed Diverse Devices as its exclusive distributor for Australia and New Zealand, and has signed Do Gia Production and Trading JSC as its exclusive distributor in Vietnam. The company's product line includes the...
Highlights: ACT 1 subgroup analysis shows benefit of carotid artery stenting for women and highly atherosclerotic patients Radiation exposure during EVAR causes DNA damage in operators Aloke Finn: DCB particulate embolisation Profile: Stéphan Haulon https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/11/76-VN-US_low-res.pdf
Highlights: ACT 1 subgroup analysis shows benefit of carotid artery stenting for women and highly atherosclerotic patients Radiation exposure during EVAR causes DNA damage in operators Aloke Finn: DCB particulate embolisation Profile: Stéphan Haulon https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/11/76-VN-EU_low-res.pdf
Getinge has installed the 1,000th hybrid operating room (OR) worldwide. West Virginia University (WVU) Heart and Vascular Institute, in Morgantown, USA, has installed three new, state-of-the-art hybrid ORs. Designed for patients requiring vascular or structural heart procedures, Hybrid ORs...
Bayer and its cooperation partner Janssen Research & Development have announced two publications of further data from the Phase III COMPASS study in The Lancet, one in patients with peripheral artery disease (PAD) and the other in patients with...
Vascular Flow Technologies (VFT) has announced the successful conclusion of a strategic intellectual property out-licencing agreement with Biovic Sdn bhd. Biovic are a Malaysia-based high tech biomedical company focussed on meeting the needs of patients in developing medical communities with...
Positive single-centre 24-month results from Intact Vascular’s TOBA (Tack optimised balloon angioplasty) clinical study were presented at the 2017 VEITHsymposium 2017 (14–18 November, New York City, USA) by Christian Wissgott (Westküstenklinikum Heide, Heide, Germany). The TOBA study enrolled 138 subjects at 13 sites in Europe....
A 53-year-old woman with a complex aortic malfunction causing a bulging blood vessel attended University Hospital Mainz (Mainz, Germany), having been rejected by several other hospitals due to the risky nature of her required surgery. Bernhard Dorweiler— head of...
Cagent Vascular has announced the issuance of its CE marking for the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. Cagent Vascular has also achieved its ISO 13485 Certification. The Serranator is one of a family of peripheral artery disease (PAD) technologies...
Philips has announced the results of an independent two-year study on clinicians' use of Azurion, the company's image-guided therapy platform, at St. Antonius Hospital. The study finds that use of Azurion by clinicians in the hospital resulted in significant...
At the European Society for Vascular Surgery (ESVS) meeting (19–22 September, Lyon, France), Vascular News spoke to Florian Dick (University of Bern, Bern, Switzerland) about the new Global Vascular Guidelines for chronic limb-threatening ischaemia, which were presented to delegates...
Percutaneous closure of large-bore arterial access sites using the Perclose ProGlide suture-mediated closure device (Abbott Vascular) is associated with significantly lower rates of blood transfusions, infections, mortality and length of hospital stay, compared with surgical cutdown in a real-world...
An innovative, investigational treatment approach is showing the potential to address an important, unresolved problem encountered by patients with kidney failure on dialysis. At the recent annual meeting of the American Society of Nephrology (ASN), Vascular Therapies presented preliminary...
Nitiloop has received FDA clearance for its new Nova Cross Extreme and Nova Cross BTK. According to the company, these dedicated microcatheters are joining the Nova Cross product family “combining innovative low profile microcatheter technology with uniquely designed nitinol scaffold providing enhanced guidewire and microcatheter...
Mercator MedSystems has announced completion of enrolment in the company’s LIMBO-ATX (Lower-limb adventitial infusion of dexamethasone via Bullfrog to reduce occurrence of restenosis after atherectomy-based revascularization) clinical trial. The LIMBO-ATX trial was designed to use Mercator’s proprietary Bullfrog micro-infusion...
Gore has announced the first patient enrolment in its post-market European registry for the Gore TAG Conformable Thoracic Stent Graft with Active Control System, following its recent European launch in July 2017. The thoracic endovascular aortic repair (TEVAR) device is...
Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy System for treating in-stent restenosis (ISR) in lower extremity arteries. Up to 140 patients will be...
Symic Bio has announced results from the phase I/II SHIELD trial evaluating SB-030, a locally administered therapeutic, in patients with peripheral vascular disease undergoing angioplasty. In this first-in-human, prospective, randomised, single-blind controlled study of 67 patients, SB-030 demonstrated a...
The health implications of prolonged low dose radiation exposure are frequently a topic of discussion amongst vascular interventionalists, who are performing a growing number of fluoroscopically guided procedures of increasing complexity. Anecdotal evidence points to an alarming pattern of...
Over the past few years, we have seen an increased awareness of the role of mental health in several health outcomes, note Marlene Grenon and Greg J Zahner. One may wonder what is happening with our patients who suffer from vascular...
Surmodics has announced enrolment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to a...
Endologix has appointed John Onopchenko as the company's chief operating officer, effective as of 30 October, 2017. Onopchenko will be responsible for managing Endologix's manufacturing, supply chain, and quality organisations. A press release explains that Onopchenko brings almost thirty years...
The European Commission has approved, under the EU Merger Regulation, the acquisition of Bard by BD. The decision is conditional on the divestment of BD's core needle biopsy devices business, and tissue marker product that is currently under development. CR...
HyperMed Imaging is now selling its new HyperView imaging system to customers in the USA. The HyperView system is US Food and Drug Administration (FDA)-cleared, and, according to a company press release, represents “a new standard of performance when assessing...
Garen Wintemute (Violence Prevention Program, University of California Davis, USA), in an editorial in the Annals of Internal Medicine, has called for physicians to make a public commitment to talk to their patients about firearms, counsel them on safe...
Vivasure Medical has announced the successful enrolment of the first patient in the Frontier IV clinical study, a non-randomised multicentre international trial, designed to expand the indications of its proprietary PerQseal large arteriotomy closure technology. The patient was enrolled...
Silk Road Medical has announced the appointment of Tammy Leitsinger to the position of vice president, Medical Affairs and Professional Education. In this new role, Leitsinger will further develop and refine global, peer-to-peer transcarotid artery revascularisation (TCAR) training pathways and innovative...

Thomas Schmitz-Rixen

Thomas Schmitz-Rixen initially considered being a sociologist. However, he began to gravitate towards the world of medicine following a discussion with his school principal. His first interest in vascular medicine came from watching microvascular surgery on television, a procedure...
The US Centers for Medicare and Medicaid Services (CMS) has determined that there is now sufficient evidence to cover supervised exercise therapy for the treatment of intermittent claudication. This decision will likely provide a boost to supervised exercise therapy...
Shockwave Medical has reported US$35 million in new financing, an extension of the company’s previously announced US$45 million Series C financing. New investor Fidelity Management & Research Company participated, along with certain funds and accounts advised by T Rowe Price...
  Medtronic has received US Food and Drug Administration (FDA) approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60 degrees infrarenal angulation when used in combination...
CryoLife has entered into a definitive agreement to acquire Jotec AG. A press release states that the combination of CryoLife and Jotec will create a company “with a broad and highly competitive product portfolio focused on aortic surgery, and...
Essential Medical has announced initiation of enrolment in a post-market clinical registry in the regions where Manta is commercially available. Principal investigator Nicolas Van Mieghem, medical director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, the...
Endologix has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a confirmatory clinical study (EVAS2) to evaluate the safety and effectiveness of the Nellix endovascular aneurysm sealing system (EVAS) for the treatment of...

BTG acquires Roxwood Medical

BTG today announces it has acquired Roxwood Medical, an innovative provider of advanced cardiovascular specialty catheters used in the treatment of patients with severe coronary and peripheral artery disease. Roxwood's anchoring catheters (CenterCross, CenterCross Ultra, MultiCross) and microcatheters (MicroCross) offer...
Essential Medical has announced the completion of enrolment in the US pivotal investigational device exemption (IDE) trial of the Manta large bore vascular closure device. The device is a novel CE Marked vascular closure device designed to close punctures...
The first patient was treated in the CONTROL hypertension (HTN)-2 clinical study, the Rox Medical’s pivotal study to evaluate the safety and effectiveness of the Rox Coupler used to create an arteriovenous anastomosis in the iliac vessels, in patients...
The US Food and Drug Administration has cleared Adhezion Biomedical’s  SecurePortIV catheter securement adhesive for marketing. The adhesive is comprised of a cyanoacrylate formulation. It can be used with short-term or long-term vascular access devices to enhance device securement, seal...
The first patient has been enrolled in Bolton Medical’s RelayPro US Food and Drug Administration (FDA) Phase II clinical trial. This study will assess the safety and efficacy of RelayPro to treat Type B dissections. Christian Shults, cardiothoracic surgeon and Tareq...
The first US patient has been treated with VentureMed Group’s Flex scoring catheter. The catheter is used to treat patients with end-stage renal disease. "Many end-stage renal disease patients receive many years or even decades of dialysis treatments," says John...
iVascular SLU has announced the initiation of the TINTIN trial, evaluating the combined therapy of Luminor drug-coated balloon (DCB) and iVolution self-expandable stent. The TINTIN study is prospective, investigator-initiated, non-randomised, multicentre trial, investigating the 12-month safety and efficacy of combined...
At the recent Vascular Interventional Advances 2017 conference (VIVA; 11–14 September, Las Vegas, USA), Vascular News caught up with Philips' Atul Gupta (Global Chief Medical Officer, Image Guided Therapy) and Will Martin (Peripheral Segment Leader, Image Guided Therapy) to...
TVA Medical’s everlinQ 4 endovascular arteriovenous fistula (AVF) system has received CE mark in the European Union. The technology uses a 4F catheter system with enhanced visual indicators to create haemodialysis access using an endovascular technique without open surgery. In...
It is now almost a decade since the first patient underwent catheter-based renal denervation as a participant in a safety and proof-of concept study (SYMPLICITY HTN-1).1 Since then, SYMPLICITY HTN-3 has indicated that renal denervation does not provide benefit...
Preliminary 30-day data from the PRELUDE trial investigating the use of the Serranator Alto percutaneous transluminal angioplasty (PTA) serration balloon catheter (Cagent Vascular) have shown 100% technical success and good effectiveness in moderate to severe calcification in the superficial...
In this supplement: -Altura has the potential to significantly improve many facets of EVAR performance -Early Altura data show “very encouraging” safety and effectiveness outcomes -Performance of Aorfix with IntelliFlex LP delivery system in challenging anatomy -PYTHAGORAS US clinical...
New ACT 1 subgroup analysis demonstrates that in female patients the rate of ipsilateral stroke is lower with carotid artery stenting (CAS) compared with endarterectomy (CEA), while in highly atherosclerotic patients stenting seems to deliver better overall long-term results...
Lombard Medical has announced the full commercial launch in Japan of its new low-profile IntelliFlex LP delivery system for the Aorfix abdominal aortic aneuryism (AAA) system. The new delivery system, used to deliver Lombard’s Aorfix AAA stent graft, is exclusively...
Benjamin Starnes, chief of Vascular Surgery at the University of Washington (Seattle, USA), has reported successful results for the first 30 patients undergoing fenestrated endovascular aneurysm repair (FEVAR) planned and performed using Aortica’s AortaFit automated case planning software. The cases...
iVascular SLU has announced that it has received approval for selling its coronary and peripheral products in India. The Indian medical devices market is the fourth largest in Asia and part of the global top 20. “iVascular’s product portfolio was created...
Lombard Medical has announced the appointment of Jonathan Hornsby as vice president of sales and marketing, effective immediately. Jonathan Hornsby brings over 20 years of experience in the endovascular aortic repair business. He has been instrumental in several product launches,...
A new analysis published by The Sage Group has concluded that 42–60 million Chinese citizens are afflicted by peripheral artery disease (PAD), with 5.6–6.3 million suffering from the most severe form of PAD, critical limb ischaemia (CLI). “China is known...
iVascular has announced that its Luminor 14m peripheral balloon catheter with paclitaxel elution has received the Canadian Medical Device Licence (MDL). Luminor 14m is a drug-coated balloon (DCB) with the combination of an extra low cross profile and iVascular proprietary...
Medtronic is expanding its embolisation product portfolio with the launch of the Concerto 3D detachable coil system. The system was launched at the Cardiovascular and Interventional Radiological Society of Europe annual meeting (CIRSE; 16–20 September, Copenhagen, Denmark). The Concerto 3D...
Shockwave Medical has reported positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe congress (CIRSE; 16-20 September, Copenhagen, Denmark). “The results of this study are consistent with findings from...
Endologix has been granted CE mark approval for its Nellix endovascular aneurysm sealing system, with refined Instructions for Use (IFU). Nellix is being studied in the USA under a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE). Nellix...
Highlights: -Patient adherence, funding and physician interest remain barriers to supervised exercise therapy -Depression and peripheral disease -The ageing surgeon -Profile: Thomas Schmitz-Rixen https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/09/Vascular-News-75-US-low-res.pdf
Highlights: -Patient adherence, funding and physician interest remain barriers to supervised exercise therapy -Depression and peripheral disease -The ageing surgeon -Profile: Thomas Schmitz-Rixen https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/09/Vascular-News-75-EU-low-res.pdf
InGeneron has announced the publication of results from an investigator initiated case series in chronic leg wounds in the Journal of the European Academy of Dermatology and Venereology. In the case series, InGeneron’s proprietary adipose-derived regenerative cell (ADRC) technology was...
Aplagon and Cadila Pharmaceuticals Sweden AB have announced a development and commercialisation agreement for Aplagon’s lead APAC product. APACs are proprietary, locally acting, potent antithrombotic products, which target blood vessel wall injury. Under the agreement, Cadila Pharmaceuticals Sweden AB together with...
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce restenosis rates, according to results from various Biotronik studies presented at the 2017 Cardiovascular and Interventional Radiological Society of Europe meeting (CIRSE; 16-20 September,...
Getinge has entered into a partnership with Contego Medical. Getinge will distribute Contego’s products in Germany, France, Spain, Portugal, the UK, Netherlands, Belgium, Austria and Scandinavia, with the potential to expand into other territories. Getinge will distribute the Paladin carotid...
Data have been announced demonstrating the efficacy of iVascular’s Luminor drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) at six months. The results from the full clinical cohort of the EffPAC randomised study were presented in the...
The three-year results from the MAJESTIC trial for Boston Scientific’s Eluvia paclitaxel-eluting vascular stent system at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 16-20 September, Copenhagen, Denmark). The data demonstrated that in this study, long-term treatment durability...
The Court of Dusseldorf, Germany, has recognised in full the CID-Alvimedica rights on intellectual properties regarding the principles and related technology on drug release from a stent through reservoirs on the outer surface (abluminal reservoir technology) and issued an...
CBSET, a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies, has announced that its scientists have published data and analyses (titled, Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis) that...
Surmodics has received US Food and Drug Administration (FDA) 510(k) and CE mark clearance for its 0.014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for peripheral angioplasty procedures. The company is making this product available for distribution...
Philips has announced the two-year results from the ILLUMENATE European randomised clinical trial (EU RCT) demonstrating the efficacy of the Philips Spectranetics’ Stellarex 0.035” drug-coated balloon (DCB) for peripheral artery disease (PAD) in comparison to uncoated balloon angioplasty. Marianne...
Following FDA approval of its PMA supplement, Vasorum has added a 7F Celt ACD vascular closure device to its Celt ACD 6F and Celt ACD 5F range in the USA. Celt ACD is indicated for arterial puncture closure in both...
Gecko Biomedical has received CE mark approval for its Setalum sealant allowing the company to market its technology in Europe. The Setalum sealant is a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments as an add-on...
The Castor branched aortic stent graft system, developed by MicroPort Endovascular, has obtained the regulatory approval from China Food and Drug Administration (CFDA), formally entering the Chinese market. Thoracic endovascular aortic repair (TEVAR) for the treatment of aortic dissection has...
Data from the Surmodics PREVEIL early feasibility study of the company’s SurVeil drug-coated balloon (DCB) was shared in a late-breaking clinical trial presentation at the Vascular Interventional Advances meeting (VIVA; 11-14 September, Las Vegas, USA). PREVEIL is a prospective, US,...
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour system for treating long-segment (>25cm) blockages in the femoropopliteal artery. The data were presented as a late-breaking clinical trial session...
Lombard Medical has announced completion of a restructuring following the implementation of its new strategy to focus sales efforts in the UK, Japan and China, and reduce operating and manufacturing costs in order to achieve cash flow breakeven in...
Five-year data from Medtronic’s ENGAGE global registry indicate that endovascular aneurysm repair (EVAR) outcomes are comparable between male and female patients when using the Endurant II stent graft (Medtronic). The five-year ENGAGE global registry data were presented for the first...
Endologix has signed a joint research and development agreement, as well as an exclusive distribution agreement, with Japan Lifeline (JLL) pertaining to the development and distribution of novel endovascular stent graft systems for the treatment of thoracic aortic diseases. Under...
Medtronic has released data reinforcing the durability and safety of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD). The two-year, real-world results from the full clinical cohort of the IN.PACT Global Study and four-year...
New significant outcomes from the Mimics study have been presented at the 15th annual conference on Vascular Interventional Advances (VIVA; 11-14 September, Las Vegas, USA). The data were presented by Thomas Zeller (Unversitaets Herzzentrum, Freiburg, Bad-Krozingen, Germany). The BioMimics 3D...
Contego Medical has announced the initiation of the ENTRAP Study evaluating usage of its Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection in patients receiving peripheral angioplasty. The first cases with the device were performed by Ralf...
Data from the LOCOMOTIVE trial—a trial investigating the VascuFlex Multi-LOC multiple stent delivery system (MSDS; B Braun)—revealed that the strategy was safe and effective for focal stenting in long femoropopliteal lesions. The system achieved primary patency of 90.7% (n=68/75)...
Medtronic announced on 8 September 2017 that the IN.PACT Admiral drug-coated balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries....
Gardia Medical has announced that, according to the independent Clinical Events Committee (CEC), the company has successfully met the primary endpoint in its WISE-LE study. The WISE-LE study's objective is to demonstrate the safety and performance of the Wirion EPS...
RD Global-Invamed has announced it has received CE marking to market the Extender drug-coated balloon (DCB) and Temren atherectomy with CTO catheter for treating arterial occlusions.  According to RD Global-Invamed, with the new Extender DCB and Temren atherectomy with CTO...
December 2017 will mark an important change in to US Medicare reimbursement for drug-coated balloons (DCBs) which could create an access barrier to DCB treatment and reduced therapy adoption in patients with peripheral artery disease (PAD). The recently-released CY 2018...
European Society of Cardiology (ESC) Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, developed in collaboration with the European Society for Vascular Surgery (ESVS), have been published in the European Heart Journal, European Journal of Vascular and...
PIUR Imaging has announced the launch of new applications for their vascular tomographic ultrasound solution, PIUR tUS, in Europe. The new applications include three-dimensional (3D) ultrasound angiography for high-resolution imaging of carotid stenosis and multi-scan acquisitions that allow large...
In this supplement: -Individualised therapy through high-precision technology -Treatment of juxtarenal aneurysms with patient-adapted fenestrated stent graft solutions -Treatment of thoracoabdominal aneurysms with custom-made stent grafts -Customised endoprostheses for the treatment of iliac aneurysms https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/09/VN-JOTEC_Final-for-web.pdf
The European results of the first-in-human trial of Vascular Dynamics’ MobiusHD implant indicate that the device is associated with a reduction in 24-hour ambulatory systolic blood pressure of 21mmHg from baseline at six months after implantation in patients with...
The COMPASS study, which was presented at the European Society of Cardiology (ESC) congress (26–30 August, Barcelona, Spain), has shown that rivaroxaban (Xarelto, Bayer) 2.5mg twice daily, plus aspirin 100mg once daily, is associated with a 24% relative risk...
Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a new indication and is now available for sale in the USA. With this approval, the Lutonix...
Access Vascular has announced US$3.7m in funding from individual investors and angelMD, an investment platform and marketplace connecting innovative medical start-ups, physicians, investors and industry partners. This financing will help support submission of a 510(k) application later this year, for Access...
Drug-coated balloon treatment for vascular access stenosis offers a real alternative to plain balloon angioplasty, reducing the rate of reinterventions and prolonging the lifespan of arteriovenous fistulae, according to the most recent data from the APERTO Italian Registry.  At the 2017...
A US study based on the largest representative sample of e-cigarette users to date has provided evidence that e-cigarette use is associated with an increase in smoking cessation at the population level. Published online in the British Medical Journal, Shu-Hong...
Data from the PATENCY-1 trial indicate that the application of vonapanitase (Proteon Therapeutics) at the time of fistula surgery is associated with increased fistula survival and use for haemodialysis. Steven Burke, chief medical officer for Proteon Therapeutics, told delegates at...
Getinge has announced the full US market release of the Pulsar-18 stent from Biotronik. Pulsar-18 is the only available self-expanding stent for blocked superficial femoral arteries with a 4F delivery system. Getinge currently distributes Biotronik’s portfolio of products to...
Cook Medical is recalling the Zenith Alpha thoracic endovascular graft when used for the treatment of blunt traumatic aortic injury because thrombus may form inside the device after implantation. Cook Medical is also aware of reported cases where the...
Endologix has announced positive interim results from the LEOPARD (Looking at EVAR outcomes by primary analysis of randomised data) clinical study. LEOPARD is the first and only head-to-head, prospective, multicentre, randomised clinical study comparing currently available endovascular abdominal aortic...
Laminate Medical has announced the success of the first four Spanish clinical cases using the VasQ device. The cases were performed by Gaspar Mestres at Hospital Clinic of Barcelona, Vascular Surgery Division, Spain, which is led by Vicente Riambau The VasQ...
On 30 June 2017, Lombard Medical notified the UK Medicines and Health products Regulatory Agency (MHRA) about problems with the Altura stent graft device. The letter stated that all lot numbers in the catalogues 01-AA-24-090, 01-AA-27-090 and 01-AA-30-090 were being recalled. According...
Philips has completed the acquisition of Spectranetics. Spectranetics’ financial results will be consolidated as part of Philips’ Image-Guided Therapy business group as of August 9, 2017. Spectranetics is currently growing quickly, and projects 2017 sales to be approximately US$300 million....
QT Vascular has started enrolment in its US pivotal clinical study. The study will evaluate the company's Chocolate Touch drug-coated balloon (DCB), for use in superficial femoral and popliteal arteries. The study is intended to support US Food and Drug Administration...
One-year data from Cardiovascular System’s all-comers LIBERTY 360 clinical study have demonstrated sustained benefits following endovascular intervention in critical limb ischaemia patients. The data were presented during a late-breaking presentation at the 2017 Amputation Prevention Symposium (AMP) in Chicago, USA. The...
A new sub-analysis from Cardiovascular System’s LIBERTY 360 study supports the use of the company’s Diamondback 360 peripheral orbital atherectomy system (OAS) during endovascular intervention for Rutherford Class 2–6 patients. The results were presented as part of a late-breaking presentation...
Essential Medical has announced that more than 1,000 Manta large bore vascular closure devices have been successfully deployed globally. To meet the growing demands of the large bore closure market, Essential Medical is also increasing their production capacity with...
Results published in Diabetes Care demonstrate that the Podimetrics SmartMat detected as many as 97% of developing nontraumatic plantar foot ulcers on average five weeks before they presented clinically. Importantly, 86% of patients used the mat at least three times per...
Type B aortic dissection (TBAD) patients exhibit poor adherence to best medical therapy, which may play a part in the high levels of aortic morbidity and mortality seen in this patient cohort, according to research presented by Colin Bicknell...
Atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments for claudication in outpatient settings may result in outcomes worse than the natural history of the disease, according to data presented at the 2017 Vascular Annual Meeting (VAM; 30...
Bard Peripheral Vascular has announced it has received CE marking to market the Covera Plus vascular covered stent. According to Bard, with the new Covera Plus covered stent, the Bard Covera covered stent product family is expanding its treatment options...
Laminate Medical Technologies, an Israeli biomedical start-up developing VasQ, an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for haemodialysis, announced on 1 August 2017 that it has received investigational device exemption (IDE) approval...
The Society for Vascular Surgery (SVS) executive board has established a task force to explore developing a vascular certification program for inpatient and outpatient care settings. Noting the shift in professional reimbursement from payment for volume to payment for quality,...
LimFlow announced on 1 August 2017 publication of positive results from the pilot study of the LimFlow Percutaneous Deep Vein Arterialization System (pDVA) in the July issue of the Journal of Endovascular Therapy. The paper is entitled “Midterm Outcomes...
Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate the SurVeil DCB for treatment for peripheral artery...
Spectranetics has announced receipt of US Food and Drug Administration (FDA) pre-market approval of the Stellarex drug-coated balloon (DCB), designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral artery disease (PAD). “The Stellarex...
Bolton Medical has announced the first implant of the Treo abdominal stent graft system in the Treo Registry, a post-market surveillance clinical investigation that aims to assess long term real-world data of the device in a global, prospective, multicentre...
Teleflex’ Arrow Seldinger arterial catheterisation device received market clearance from the US Food and Drug Administration (FDA). The new device is indicated for short-term use. The device is designed to improve patient safety by eliminating confusion of catheter identification, reduce...
As the US Congress debates funding Medicaid and the uninsured, a new vascular study finds that hospitals with a high ratio of those two patient groups are less able to save patients who develop serious surgical complications. As reported in...
Avacen is to partner with Morulaa HealthTech of Chennai, India, to introduce its Avacen 100 class II medical device to the country. Initial focus will be to reduce the number of limb amputations resulting from diabetic foot ulcers. According to...
Fusion imaging can be used for infrarenal endovascular aneurysm repair (EVAR) following a short learning curve with the benefit of lower radiation dose and shorter procedure times, according to a presentation giving at the 2017 Vascular Annual Meeting (VAM;...
Iliac artery aneurysms—affecting up to one third of patients with complex aortic aneurysms—do not affect all-cause mortality or aneurysm-related mortality in endovascular repair of complex aortic aneurysms, according to a study presented at the 2017 Vascular Annual Meeting (VAM;...
Silk Road Medical has received US$47 million in new funding led by new investors Norwest Venture Partners and funds managed by Janus Capital Management LLC. Existing investors Warburg Pincus, The Vertical Group, and CRG also participated in the round. The...
Intact Vascular’s TOBA II BTK (Tack optimized balloon angioplasty II below the knee) clinical trial has commenced enrolment in Europe, with the first patient treated by Marianne Brodmann and Peter Reif at Medical University Graz, Austria. The TOBA II BTK study, which enrolled its first patient in...
iVascular has announced the release of Angiolite BTK, a sirolimus-eluting stent which has received CE mark approval for treating chronic and acute arterial lesions in lower limbs below the knee, improving blood flow in severe claudication and critical limb ischaemia.  The Angiolite...
The US Patent and Trademark Office has granted Ra Medical Systems a broad patent (number 9700655) that covers Ra Medical Systems’ DABRA catheter for cardiovascular disease treatment. The inventors include Ra Medical Systems director of research and development, James...
The 9th Annual Congress of the Polish Society for Vascular Surgery has now closed, following three days in which Warsaw became the world capital of vascular surgery. During the conference the leading surgeons from Poland and abroad met in...
LimFlow SA has announced enrolment of the first patient in the US feasibility study of the LimFlow percutaneous deep vein arterialisation (pDVA) system, a novel, purely percutaneous device for the treatment of end-stage critical limb ischaemia (CLI) when all other...
Gore has announced the first patient implant of the TAG conformable thoracic stent graft with Active Control system after the receipt of CE mark last month. The first implant was performed by Giovanni Torsello and Martin Austermann at St...
Following the €1.9 billion (US$2.16 billion) purchase of The Spectranetics Corporation by Royal Philips, Ra Medical Systems has announced the appointment of two new members to the company’s board of directors. This also follows the recent FDA market clearance...
The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in Intact Vascular’s TOBA II BTK (Tack optimized balloon angioplasty II below the knee) clinical trial from 12 months to six months. The TOBA II BTK study...
Richard Gibbs and colleagues have previously demonstrated that 80% of patients undergoing thoracic endovascular aneurysm repair (TEVAR) have evidence of new post-procedural cerebral infarcts by comparing pre- and postoperative diffusion-weighted magnetic resonance imaging scans. Whilst the majority have no overt stroke, the new silent...
One might regard investigating delay in the treatment of ischaemic tissue lesions pointless and absurd at first thought because nobody wants to waste any time in the treatment of ischaemic ulcers. Katariina Noronen and colleagues, however, took on the task with the aim...
We need to stop doing endovascular procedures for critical limb ischaemia patients when no measurable benefit is being seen and when the adverse event rate is increasing. Sometimes, reducing the level of amputation can be an acceptable outcome, writes Barry T Katzen.  Critical limb...
Endovascular aneurysm repair (EVAR) is a highly specialised and potentially complicated procedure requiring knowledge and skills from several cognitive domains. Indeed, EVAR involves several intricate procedural steps, which have been reflected in a flat learning curve for entry into practice. The technical...

Maarit Venermo

Maarit Venermo was driven to a life in medicine by her competitive nature, and arrived at medical school with little idea of what specialty she would end up in. As is so often the case, it was an influential mentor...
Biotronik has announced that 12-month data from the BIOFLEX-I study have demonstrated the safety and efficacy of the company’s Pulsar-18 self-expanding stent for blocked superficial femoral artery treatment. The study results were presented during a late-breaking session at the...
The UK’s Information Commissioner’s Office (ICO) has found that the Royal Free National Health Service (NHS) Foundation Trust (London, UK) did not adhere to the UK’s Data Protection Act when it provided patient details to Google DeepMind. The Trust, a...
  Royal Philips has announced the acquisition of CardioProlific Inc, a USA-based, privately-held company that is developing catheter-based thrombectomy approaches to treat peripheral vascular disease. Financial details of the transaction will not be disclosed. A company press release states that CardioProlific’s technologies...
Royal Philips and The Spectranetics Corporation have entered into a definitive merger agreement. Pursuant to the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of Spectranetics for US$38.50 per share, to be paid in cash upon completion. This...
Getinge has announced the opening of a new modern hybrid operating room (OR) in the Experience Center in Rastatt, Germany. The Hybrid OR will enable intraoperative 2D and 3D imaging during minimally invasive surgery. The Getinge Experience Center (formerly the...
The Heart Endovascular & Rhythm of Texas announced its latest collaboration with Ra Medical Systems to use the Destruction of Arteriosclerotic Blockages by laser Radiation Ablation (DABRA) system for the treatment of peripheral artery disease (PAD) in San Antonio,...
It is well known that women have worse outcomes following treatment for abdominal aortic aneurysms, but a recent study finds that the results are similar for women undergoing TEVAR (thoracic endovascular aneurysm repair) and that gender should be considered...
Shockwave Medical has announced two milestones for its Lithoplasty system for the treatment of calcified plaque in patients with peripheral artery disease (PAD): enrolment of the first patient in the global DISRUPT PAD III clinical trial at the Medical...
From 22–24 May 2017, the IX Annual Congress of the Polish Society for Vascular Surgery (PTChN) will be held in the Hilton hotel in Warsaw, Poland. For the first time, the agenda includes special sessions with representatives of three...
Public Health England (PHE) and the Royal Society for Public Health (RSPH) have published “Everyday Interactions”, a report which aims to support healthcare professionals to record and measure their public health impact.  The report and toolkit were developed in close...
New leaders have been elected at the annual business meeting of the Society for Vascular Surgery during the organisation’s annual meeting in San Diego, USA. They are: President - R Clement Darling III Darling, who served as president-elect during the past year,...
A surgical-first strategy appears to be superior to endovascular treatment for critical limb ischaemia revascularisation, exhibiting improved wound healing rate and overall healing time, according to data presented by Jin Okazaki (Kitakyushu, Japan) at the Vascular Annual Meeting (VAM;...
Fifty-two-week outcomes of the MOBILE trial indicate a “significant reduction in major amputations” among Rutherford 4 and non-diabetic Rutherford 5 critical limb ischaemia patients following the use of intramuscular injection of autologous bone marrow cells (cBMA). Keisin Wang (Indiana, USA)...
TVA Medical has announced the online publication of positive results from the Novel Endovascular Access Trial (NEAT) evaluating its everlinQ endoAVF system. The 12-month data published online in the American Journal of Kidney Diseases (AJKD), the official journal of the...
Medtronic has announced recent reimbursement approvals in both France and Belgium. A Ministerial decree was published in the Official Journal of French Republic to enlist Medtronic's IN.PACT Admiral drug-coated balloon (DCB) for the LPPR title V for add-on reimbursement in...
LimFlow, developer of minimally-invasive technology for the treatment of end-stage critical limb ischaemia (CLI), has announced the expansion of the company’s senior management team. Sophie Humbert has been appointed to the role of chief operating officer (COO) and Thomas...
At the 2017 Vascular Annual Meeting (VAM; 30 May–3 June, San Diego, USA), mid-term follow-up data from a pivotal trial (IBE 12-04) of the Excluder Iliac Branch Endoprosthesis (IBE, Gore) and the real-world GREAT Registry showed that the device...
Philips has announced the relaunch of its Pioneer Plus catheter, “the first and only re-entry device with intravascular ultrasound (IVUS) capabilities and needle deployment designed to assist arterial vessel intervention,” according to a company press release. IVUS captures images of vessels...
Cagent Vascular has announced the completion of enrolment in the first-in-human PRELUDE study. The purpose of this prospective, single-arm, multicentre feasibility study is to show the safety and efficacy of the company’s Serranator Alto device used in the superficial...
New independent data from Thomas Jefferson University in Philadelphia, USA, has demonstrated that the use of negative pressure therapy using Prevena incision management system may reduce the rate of major wound complications and associated costs following vascular groin surgery...
Positive two-year clinical data from Endologix’ Nellix EVAS FORWARD investigative device exemption trial have been presented at the Society of Vascular Surgery (SVS; 31 May–3 June) 2017 annual meeting. The trial prospectively enrolled patients with abdominal aortic aneurysms (AAA)...
To prevent surgical site infections (SSI) during abdominal aortic aneurysm repair surgery, a mainstay, widely-spread approach is to dip stent grafts in rifampicin before implantation. However, new research indicates that this approach could contribute to the global emergence of...
Highlights: -SWAN trial: Screening women for aneurysms would yield little benefit and not be cost-effective -EVAR 2 very long-term results prompt a call for shared decision-making in frail patients -Interim data from randomised trial show no benefit of liberation...
Highlights: -SWAN trial: Screening women for aneurysms would yield little benefit and not be cost-effective -EVAR 2 very long-term results prompt a call for shared decision-making in frail patients -Interim data from randomised trial show no benefit of liberation...
Avinger has announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular technology. Twenty-four-month follow-up results from 89 patients were presented by Patrick Muck, chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, USA,...
Endologix has announced 30-day results from the LUCY (Evaluation of Females who are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair) study. The data showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair (EVAR) when...
The management of type B aortic dissections represents a significant challenge for the vascular community. Despite the great advances obtained since the development of endovascular treatment, questions still remain on how to best treat complicated and uncomplicated dissections, and when. Trying...
The US Food and Drug Administration (FDA) has granted market clearance to Ra Medical Systems—makers of excimer lasers and catheters for cardiovascular and dermatological diseases—for the company’s Destruction of Arteriosclerotic Blockages by laser Radiation Ablation (DABRA) system. The system...
In this supplement: -The clinical and biological advantages of active sac management with EVAS -10 things to know about Ovation -Ovation: Finally an endograft that treats women equally https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/05/VN_Endologix-supplement_FINAL-low-res.pdf
Vascular News interviews Fabrizio Fanelli, Rome, Italy, on the results of the IN.PACT Admiral drug-coated balloon (Medtronic) in long lesions, lesions with calcification, chronic total occlusions, and TASC C and D lesions. The data were presented at the Charing...
The US Food and Drug Administration (FDA) has cleared Stroke2prevent’s A-view device for commercialisation on the US market. The A-view is a balloon catheter designed for visualisation of the aortic arch by transoesophageal echocardiography (TEE). The A-Views is intended to...
Med Alliance has announced the on-schedule completion of patient enrolment in the first-in-man (FIM) study of Selution, the company’s sirolimus-coated balloon. Fifty patients have been enrolled between 26 October 2016 and 23 May 2017 across four German centres: Franziskus...
This year Gore is celebrating 20 years of experience and innovation in the aortic space. At the Charing Cross Symposium (25–28 April, London, UK) Michael Dake, Stanford, USA, spoke to Vascular News about this milestone and about how Gore...
The first patient has been enrolled in Medtronic’s IN.PACT arteriovenous (AV) access drug-coated balloon (DCB) study for use in patients with end-stage renal disease. The US Food and Drug Administration (FDA) has approved the investigational device exemption (IDE) study to...
Gore has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare to market the Excluder iliac branch endoprosthesis (IBE), and is currently in discussion regarding reimbursement for this region. The IBE is the first off-the-shelf iliac branch...
At the 2017 Charing Cross Symposium (25–28 April, London, UK) Klaus Amendt presented six-month outcomes from the all-comers LOCOMOTIVE Registry, which is investigating the use of the VascuFlex Multi-LOC multiple stent delivery system (B Braun). Amendt explained to Vascular...
A large study of the outcomes of 3,033 patients undergoing lower extremity bypass has reported a 10.6% infection rate and identified procedural risk factors. As reported in the June edition of the Journal of Vascular Surgery, vascular surgeon Peter...
At the 2017 Charing Cross Symposium (25–28 April, London, UK), speakers and panellists discussed the challenges of endovascular aortic arch procedures and their potential impact on acute stroke. Looking at both the causes and potential solutions for this problem,...
Interim twelve-month data from the Lutonix AV Clinical Trial indicate that treatment of dysfunctional arteriovenous (AV) fistulae with Bard’s Lutonix drug-coated balloon (DCB) produces non-inferior safety outcomes and a 37% improvement in primary patency when compared with plain percutaneous...
Alucent Medical has announced that it has received US Food and Drug Administration (FDA) approval to begin Phase 1 human clinical studies of Natural Vascular Scaffolding (NVS), its novel combination drug/device therapy for the treatment of peripheral vascular disease (PVD). “We...
Endologix has met with the US Food and Drug Administration (FDA) regarding its Nellix endovascular aneurysm sealing system (EVAS System). Based upon that meeting and further internal analysis, the company has determined that it will seek US approval of the...
Lombard Medical has now enrolled and treated the first patient in its global registry to evaluate its Altura endograft system. The ALTITUDE registry (Altura impact on the treatment of abdominal aortic aneurysms using a novel D-stent EVAR design) is being conducted across a range of UK and international clinical centres to...
QT Vascular has entered into an asset purchase option agreement with Medtronic for the acquisition of the group's non-drug coated Chocolate percutaneous transluminal angioplasty balloon. The option is exercisable upon achievement of certain milestones.   “We are excited that Medtronic,...
Shockwave Medical has announced the appointment of Doug Godshall as president and chief executive officer. Godshall was most recently the chief executive officer and a director of HeartWare International, where he served for 10 years until the company was acquired...
Medeon Biodesign has received approval by the New Zealand Health and Disability Ethics Committees, Ministry of Health to commence the CE clinical trial for the XPro suture-mediated vascular closure device system (XPro system), the company's large bore closure device,...
Lombard Medical’s portfolio of endovascular stent graft systems, Altura and Aorfix, were featured in scientific presentations at the 39th annual Charing Cross International Symposium (CX; 25–28 April, London, UK). Altura presentations Combined Altura clinical data from two prospective international multicentre studies were...
In this supplement: --Life post-ATTRACT: The new challenge of DVT treatment --The future of DVT intervention in Europe: what needs to happen next --"With careful patient selection and a patent popliteal vein, DVT treatment can be completed in less...
Significant success has been achieved in treating complex proximal aneurysms using a combination of fenestrated and branched graft devices, based on a report of prospectively studied patients with complex aortic aneurysm in the May edition of the Journal of...
The Charing Cross Symposium 2017 held a special session on Thursday 27 April to remember Edward B Diethrich, who died in February. The cardiovascular surgeon, who was one of the endovascular pioneers, was the founder of the Arizona Heart...
Howard Rosen has joined Intact Vascular’s executive management team as vice president of marketing and business development. In this position, Rosen will lead the company’s efforts to prepare for commercialisation of its Tack Endovascular System for the repair of dissections...
Contego Medical has announced that it has received CE mark for its Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection. The company intends to launch the Vanguard IEP system in Europe to endovascular specialists performing lower limb...
Twelve posters selected for presentation out of 68 posters displayed were carefully reviewed by the CX Abstract Board, who decided to award their prize of a free CX 2018 registration to (San Donato Milanese, Italy) for her poster, “Study...
The CX Venous Workshop returned on Wednesday, bigger than ever before. With a new location in the Exhibition Hall and its own series of edited live case presentations, it continues to showcase innovative venous technology and offer delegates the...
For the first time, Day One of this year’s CX Venous Workshop included two edited case presentations (CX Venous Edited Cases). The standing-room only session gave delegates the opportunity to watch two innovative devices in action and quiz experienced...
First-time data presentation from the SWAN (Screening Women for Abdominal aNeurysms) project was heard at the 2017 Charing Cross Symposium (CX; 25–28 April, London, UK). The study, which used simulation to evaluate whether inviting women to be screened for abdominal aortic aneurysm would have...
A “podium first” presentation of very long-term follow-up data from the EVAR 2 trials suggests that endovascular aneurysm repair (EVAR) fails to improve all-cause mortality, but reduces aneurysm-related mortality compared to no treatment in abdominal aortic aneurysm patients who...
The US Food and Drug Administration (FDA) has approved LimFlow’s Investigational Device Exemption for a feasibility study of the company’s Percutaneous Deep Vein Arterialisation (pDVA) system. When all other therapeutic options have been exhausted and a critical limb ischaemia...
Medtronic has reported that its Endurant II abdominal aortic aneurysm (AAA) stent graft system continues to demonstrate long-term durability and consistent outcomes in a real-world setting. The five-year ENGAGE global registry data were presented for the first time at...
Mercator MedSystems has announced the first patient enrolment into the TANGO (Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee) clinical trial. TANGO will study the effects of using Mercator’s proprietary Bullfrog micro-infusion device for the adventitial delivery...
At the 2017 Charing Cross Symposium (CX; 25–28 April, London, UK), delegates heard brand new data for drug-coated balloons (DCBs) in “wider use” scenarios such as challenging lesions; one-year results for a novel DCB; and late-breaking data on downstream...
Tuesday’s CX Aortic Edited Cases session featured exciting and engaging standing-room only case presentations, including Andrew Holden’s (Auckland, New Zealand) first-in-man implantation of the Ovation Alto (Endologix). Covering thoracic, juxtarenal and abdominal cases, the packed-out session explored innovative techniques,...
The particular complexities of dealing with paediatric vessels were discussed in depth at Tuesday’s varied and informative CX Paediatric Vascular Emergencies and Case Presentations session. Covering topics as diverse as acute ischaemia from pre-term to infant and treatment for...
In Tuesday’s CX Congenital Vascular Malformations session, delegates heard about how approaching congenital vascular malformations with systematic pathways of care and classification systems can greatly assist physicians in achieving consistently successful positive outcomes. Joe Brookes (London, UK) presented on classification...
Getinge has announced that, in order to better convey its customer offering and strengthen its position, it has grouped its portfolio under one single brand – Getinge. The company has also now launched the Advanta V12 32mm balloon-expandable covered stent. A...
Positive results from the RANGER SFA trial for Boston Scientific’s Ranger paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter have been presented at the 2017 CX Symposium in London, UK. Data demonstrated that the drug-coated balloon (DCB) exhibited both a...
Two new sub-analyses from the IN.PACT Global Study of the IN.PACT Admiral in patients with peripheral artery disease have been reported at the annual 2017 Charing Cross Symposium (CX) in London, UK, one of the world’s largest educational meetings...
Bluegrass Vascular Technologies has enrolled over one third of its patients in the company's post-market SAVE (Surfacer System to Facilitate Access in Venous Occlusions) clinical study. The SAVE study is an international, prospective, multicentre clinical follow-up study designed to...
BD (Becton, Dickinson and company) has definitively agreed to acquire Bard for US$317 per common share in cash and stock, for a total consideration of $24 billion. The agreement has been unanimously approved by the Boards of Directors of both...
Kurt Lemvigh has been appointed as its new chief executive officer of Lombard Medical, effective immediately. Lemvigh is a veteran medical device executive with over 30 years of experience creating profitable growth. He currently resides in the UK and has held senior...
Simon Hubbert has stepped down from his position as chief executive officer on 18 April after serving in the role for more than six years. A search is underway for a successor and an announcement is expected in due course. Hubbert joined...
Ra Medical Systems and bo medical technologies, have announced the launch of the Dabra atherectomy system for cardiovascular and Pharos excimer laser for dermatology in Europe. Ra Medical says that its Pharos (FDA market cleared and CE mark) has more...
PinnacleHealth CardioVascular Institute has enrolled the first US patient in a trial assessing the safety and effectiveness of a new type of approach for blockages in the leg artery. DISRUPT PAD III is the largest ever multicentre randomised study to...
QXMédical has announced its sponsorship of EVARplanning.com, an online tool which helps vascular and cardiovascular specialists plan complex endovascular aneurysm repair (EVAR) procedures. Developed by Paolo Spada, endovascular surgeon at Humanitas Research Hospital (Milan, Italy), the website assists vascular specialists...
Essential Medical has announced the publication of the MANTA CE marking study results in JACC Interventions titled: “Percutaneous plug-based arteriotomy closure device for large-bore access”. This first, prospective, peer reviewed scientific evaluation of vascular access complications after large bore cardiovascular...
Lombard Medical and MicroPort Scientific Corporation have finalised the definitive agreements to their strategic partnership first announced on 19 December 2016. The partnership will allow Lombard to accelerate commercialisation in China and other global markets for its abdominal aortic aneurysms product portfolio: Aorfix, the only...
iVascular has obtained CE mark for the thrombus extraction catheter Capturer 7F. A company press release states that Capturer 7F has “outstanding extraction capacity” and “the highest aspiration speed capability on the market”. It is compatible with standard 0.014” guidewires, and...
Endologix has announced today that the first patients were treated in the ELEVATE (Expanding patient applicability with polymer sealing Ovation Alto stent graft) investigational device exemption (IDE) clinical study, the company's pivotal clinical trial to evaluate the safety and...
Highlights: -Achieving consensus via Pathways of Care -CX Venous Workshop -CX Vascular Access course -CX Peripheral and Aortic Edited Live Cases -CX ilegx Collaboration Day -CX Acute Stroke Consensus -Summary of Vascular News profiles 2016/17 https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/03/VN-CX17_low-res_US.pdf
Highlights: -Achieving consensus via Pathways of Care -CX Venous Workshop -CX Vascular Access course -CX Peripheral and Aortic Edited Live Cases -CX ilegx Collaboration Day -CX Acute Stroke Consensus -Summary of Vascular News profiles 2016/17 https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/7/2017/03/VN-CX17_low-res_EU.pdf
In a 15-year evolution, parallel graft techniques have emerged as part of the effort to rescue or preserve excluded aortic branches in the context of endograft repair of complex aortic disease. While rescue was most often central to such...
This educational supplement is only available in countries in Europe. This educational supplement explores the concept of “leaving nothing behind" in the treatment of the superficial femoral artery. By considering existing treatment algorithms and looking at existing and emerging technologies, the...
Intact Vascular’s TOBA II (Tack optimized balloon angioplasty II) clinical trial has completed enrolment. A total of 210 patients have been enrolled in TOBA II at 33 sites in the USA and Europe. The TOBA II trial is a prospective, multicentre, two-arm, non-randomised study...
The US Food and Drug Administration (FDA) has granted Humacyte’s Humacyl investigational human acellular vessel (HAV) Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate the efficient development and expedited review of the HAV...
Balloon angioplasty has been utilised in lower extremity revascularisation procedures since the 1970s, but the durability of this technique is limited by both mechanical and biological forces acting on the vessel. Operators have sought to limit the effect of...
The prevalence of abdominal aortic aneurysms in patients over 55 vary between 4% and 7.2%, depending on age, gender and geographic location. The innovative approaches of the last decades in the development of diagnostic tools and surgical management have...
Continuous aortic enlargement at the level of infrarenal aortic neck has been reported after endovascular repair (EVAR) of abdominal aortic aneurysm. Current concepts regarding the reasons for this phenomenon remain poorly understood, although it is known that the amount...
Updated European Society for Vascular Surgery (ESVS) clinical practice guidelines regarding the management of diseases of the descending thoracic aorta have been published in the European Journal of Vascular and Endovascular Surgery. Chaired by Vincent Riambau, Barcelona, Spain, the Descending...
The Tsimane people—a forager-horticulturalist population of the Bolivian Amazon—have the lowest reported levels of vascular aging for any population, with coronary atherosclerosis five times less common than in the USA, according to a study published in The Lancet and presented at...
Unfors RaySafe has introduced the RaySafe i3, to its suite of real-time dosimetry products, at the European Society of Radiology in Vienna.   The RaySafe Real-Time Dosimetry solution, introduced in 2012, helps physicians and clinical staff visualise X-ray exposure in real...
Corindus Vascular Robotics has announced the closing of its previously announced private placement pursuant to which it issued and sold an aggregate of 68,055,700 shares of its common stock at a purchase price of US$0.6616 per share, resulting in...
The 2017 International Society for Vascular Surgery (ISVS) annual meeting will be held in Sibiu, Romania from 19–22 July. Vascular News spoke with Sherif Sultan (Galway, Ireland), current president of the Society, about why Romania was chosen to host...
The use of GPS mapping tools has become a cornerstone of modern life. A study published by the Journal of Vascular Surgery has demonstrated the clinical opportunities offered by this revolutionary technology, potentially allowing vascular surgeons to accurately measure...
Even after adjusting for differences in age and comorbidities, female patients have higher perioperative mortality and lower long-term survival after thoracic endovascular aneurysm repair (TEVAR), according to a study published by the Journal of Vascular Surgery. Although differences between males...
Teleflex has announced 510(k) clearance by the Food and Drug Administration and US commercial launch of the Spectre guidewire. The Spectre guidewire is engineered with a smooth stainless steel-to-nitinol dual-core transition that balances strength and agility. It is a 0.014”...
Nobilis Health has closed its previously announced acquisition of Hamilton Vein Center. “Hamilton Vein Center not only increases our in-network patient volume mix to over 60%, but its six facilities enhance our network of physicians, allowing Nobilis to generate additional...
PQ Bypass has announced CE mark approval for a trio of proprietary devices: the Torus stent graft system, PQ Snare, and PQ Crossing Device, which enables physicians to perform a fully percutaneous femoropopliteal bypass in patients with TASC II...
AV Medical Technologies has announced that its Chameleon PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic or therapeutic fluids. “The Chameleon balloon offers advantages for experienced operators as well as those training...
The new Acuson Freestyle Elite ultrasound system can now be combined with the Artis angiography systems to enable fast and easy-to-use ultrasound guidance during interventional procedures, according to a press release from Siemens Healthineers. This combined solution, referred to as...
Changes in tiny blood vessels of the eye may predict a higher risk of later narrowing in the large blood vessels in the legs, according to a study presented at the American Heart Association's Epidemiology and Prevention Lifestyle and...
Medtronic has launched the IN.PACT BTK study to evaluate the effectiveness of using a drug-coated balloon in patients with below-the-knee (BTK) peripheral artery disease. This study will evaluate the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty balloon catheter. This is an...
Scott Trerotola presented the first release of eight-month data from the Lutonix AV trial at the Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany) and showed that the drug-coated balloon (Lutonix 035 AV, Bard) is linked with a significantly...
Gore has announced the Health Canada approval of the Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design. The device, which gained CE mark approval in 2011, is a third generation, self-expanding stent. The device was designed...
Data from the randomised controlled ATTRACT trial revealed that the addition of catheter-based intervention to standard-of-care anticoagulation failed to significantly decrease the occurrence of post-thrombotic syndrome in patients who received this treatment strategy when compared to its occurence in...
Bluegrass Vascular Technologies is entering into a strategic relationship with Merit Medical Systems. The agreement will streamline European distribution of the recently CE mark-approved Surfacer Inside-Out access catheter system and will provide funding to support the company's efforts to secure US...
The US Centers for Medicare & Medicaid Services (CMS) have released the proposed decision memo for the approval of supervised exercise therapy for the treatment of peripheral artery disease (PAD). This was triggered by the receipt last year of...
Three global registries reported fresh data at the 2017 Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany), all of which showed encouraging outcomes for drug-coated balloon treatment, one at six months’ follow-up and two at one year. The data...
In a first-time data release, Dierk Scheinert presented six-month outcomes from the DETOUR trial of percutaneous bypass in long segment femoropopliteal occlusions at the Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany). The DETOUR (PQ Bypass) percutaneous bypass procedure is...
Mahmood Razavi and George Adams, the national co-principal investigators of Mercator MedSystem’s DANCE trial, have each presented comprehensive 13-month data from the trial during late-breaking sessions at International Symposium on Endovascular Therapy (ISET; 4–8 February, Holywood, USA) and Leipzig...
North Dallas Research Associates, Dallas, Texas, and its private practice, Cardiac Center of Texas, have announced their participation in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial. Using the Tack endovascular system (Intact Vascular), the...
Results from two Asian studies presented at LINC 2017 (24–27 January, Leipzig, Germany), show encouraging outcomes for drug-coated balloon versus percutaneous transluminal angioplasty treatment at 12 and 24 months. The Chinese AcoArt I trial found “sustained durability” of the...
Twelve-month results of the CONSEQUENT trial have shown lower late lumen loss, lower rates of 12-month target lesion revascularisation and longer walking distance increases for patients treated with the SeQuent drug-coated balloon (B Braun) compared with plain balloon angioplasty....
Alvimedica’s Illumina study enrolment is now complete. The Illumina study has been designed to evaluate the efficacy and safety of the new NiTiDES self-expanding polymer free drug-eluting stent for the superficial femoral artery, manufactured by CID SpA, a member...
Registration is now open for the 2017 Vascular Annual Meeting, scheduled for 31 May–3 June in San Diego, USA. Plenaries and exhibits open on 1 June. To see details and register, visit vsweb.org/VAM17. The event will be at the San...
The development of endovascular stent grafts in the descending aorta has significantly reduced the number of open surgical repairs being performed. However, the ascending aorta may be considered one of the last frontiers of endovascular aortic treatment, and encompasses...
BTG has announced US Food and Drug Administration (FDA) 510(k) clearance has been granted to the EKOS Control Unit 4.0. The EKOS system includes an ultrasonic device that uses acoustic pulses, powered by the new Control Unit 4.0, to quickly and...
Cagent Vascular has announced US Food and Drug Administration 510(k) clearance of its lead product, the Serranator Alto percutaneous transluminal angioplasty serration balloon catheter. The Serranator is the first of a family of peripheral artery disease technologies under development which incorporate...
Conflict has forever been a catalyst for medical advances. In the 20th century, for example, two World Wars and innumerable smaller civil and interstate conflicts provided fertile ground for medical innovation and experimentation. To name only a few well-known...

Obituary: Edward B Diethrich

Edward B Diethrich, an internationally esteemed cardiovascular surgeon, inventor, and philanthropist, succumbed to complications of a brain tumour on 23 February at the age of 81. Regarded as a pioneer in non-invasive cardiovascular disease diagnosis and innovative surgical and minimally...
On the night of 13 November 2015, bombing and shooting attacks in Paris, France, killed 130 people and wounded another 352. The attacks—targeting a football match, a music venue and several bars and restaurants—were the deadliest in France since...
Symic Bio, has completed enrolment for the SHIELD clinical trial of SB-030 in peripheral artery disease. The trial will evaluate the safety and efficacy of SB-030, a locally administered single-use therapeutic, in the reduction of restenosis following angioplasty. “We are...
Cook has extended its Zilver PTX product portfolio with a 140mm drug-eluting stent. Physicians will now be able to treat longer lesions with just one stent, which is deployed via a thumbwheel delivery system. A Cook press release states that...
Benjamin W Starnes, chief of Vascular Surgery at the University of Washington, USA, and one of the world’s foremost authorities on the treatment of abdominal aortic aneurysms, has announced midterm results from his physician-sponsored investigational device exemption (IDE) study,...
Philips has announced the global launch of Azurion, its next generation image-guided therapy platform that integrates advanced interventional tools into one clinician platform. Azurion is the next generation image-guided-therapy platform to enhance patient care and optimise lab productivity, a...
The pivotal VeClose trial is investigating the performance of the VenaSeal cyanoacrylate-based adhesive (Medtronic) for vein closure. At LINC 2017, Vascular News caught up with Raghu Kolluri (OhioHealth Vascular Institute, Columbus, USA) who explained his experience with the system...
Teleflex Incorporated has completed its previously announced acquisition of Vascular Solutions. On December 2, 2016, the two companies announced a definitive agreement for Teleflex to acquire all of the issued and outstanding shares of Vascular Solutions common stock for...
Heavy alcohol drinking habits over the years may prematurely age arteries, especially in men, putting them at an increased risk for heart disease, according to new research in Journal of the American Heart Association, the open access journal of...
At LINC 2017 Vascular News spoke to Peter Schneider (Kaiser Foundation Hospital, Honolulu, Hawaii, USA) about the Tack endovascular system (Intact Vascular), an implant designed to repair dissection damage done to the arterial wall during angioplasty treatment with minimal stress to the...
By Nicola Troisi, Department of Surgery, Vascular and Endovascular Surgery Unit, San Giovanni di Dio Hospital, Florence, Italy Endovascular treatment is now the preferred treatment method for symptomatic patients with atherosclerotic disease of the iliac arteries (the “endovascular-first” approach). The...
Renal failure affects millions of patients worldwide, with many renal failure patients progressing to end-stage renal disease, requiring dialysis treatment. Dialysis options include central catheters, peritoneal dialysis or haemodialysis via fistulae. Autogenous fistulae are preferred, but development of these fistulae...
Primary chronic venous disease is poorly documented in paediatric patients, excluding those diagnosed with Klippel-Trenaunay syndrome (KTS) and post-thrombotic syndrome, writes Dawn Coleman. The Bochum Study previously studied 136 children (aged 10–12 years) longitudinally out to 31 years and...
Having received CE mark approval in July and Health Canada approval in August of last year, FlowAid Medical Technologies has now received US Food and Drug Administration (FDA) clearance for its FA100 SCCD (Sequential Continuous Contraction Device) for the following indications: increase of...
Laminate Medical Technologies has announced the close of a US$8m Series B financing round. This round of funding will help finance continued development and marketing of VasQ. “The funding will enable us to expand our activities in the European market,...
Endologix has completed patient enrolment in the Lucy (Evaluation of females who are underrepresented candidates for abdominal aortic aneurysm repair) study, a multicentre post-market registry designed to explore the clinical benefits associated with endovascular aneurysm repair (EVAR) using the...
Although arteriovenous (AV) fistulae are considered the gold standard for vascular access for haemodialysis and have a low rate of complications and improved longevity of use when functional, more than 50% fail within one year of creation, necessitating reinterventions...
A tunneled catheter remains the most common access in patients initiating haemodialysis.1 This is most likely because the catheters are ready to use immediately after insertion, with no maturation time needed. As with any other dialysis access, hydraulic performance...
Micro Medical Solutions (MMS) has received CE mark approval for MicroStent, allowing the company to market this technology in Europe. MicroStent is a vascular stent specifically designed to reduce below-the-knee amputations for critical limb ischaemia (CLI) resulting from peripheral...
Intact Vascular’s TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical trial has commenced enrolment, with the first patient treated by Joseph Cardenas at Yuma Regional Hospital and the Heart, Lung and Vascular Center in Yuma, USA. The TOBA II BTK study is a...
In this clinical study the one-year results of the endovenous laser therapy (ELT) application of 1,940nm laser (Vela XL, Boston Scientific) with respect to feasibility, efficacy and safety are reported. Anna Esipova and colleagues investigated the performance of longer...
Medtronic Canada, a subsidiary of Medtronic, has announced it has obtained Health Canada licence for the IN.PACT Admiral drug-coated balloon. IN.PACT Admiral is a primary endovascular device used in patients with peripheral artery disease in the upper leg, specifically, in...
Flow Forward Medical has announced the completion of a preclinical study and a computational fluid dynamics study supporting continued development of the company's Arteriovenous Fistula Eligibility (AFE) system. The AFE system is a small external blood pump designed for...
At LINC 2017 (24–27 January, Leipzig, Germany), Luis Mariano Palena (Policlinico Abano Terme, Abano Terme, Italy) presented an update on the SUPERSUB trial, which is investigating the use of the Supera stent (Abbott Vascular) for subintimal recanalisation in critical...
The question is often asked: is intravascular ultrasound (IVUS) necessary in a deep venous practice? Stephen Black writes that it was certainly a question that he had asked when initially building his practice. The answer predominantly seemed to be that...
Houston Methodist Hospital has become the first US institution to implant the newly FDA-approved Viabahn VBX balloon expandable endoprosthesis (VBX stent graft; Gore), to successfully restored blood flow to a patient’s blocked iliac arteries. Jean Bismuth, a vascular surgeon with...
The one-year clinical outcomes from the MDT-2113 IN.PACT SFA Japan trial have been released. The data was recently presented by Osamu Iida, Kansai Rosai Hospital, Hyogo, Japan at the LINC 2017 conference (24–27 January, Leipzig, Germany), and reinforced the...
The phase three COMPASS trial, evaluating the efficacy and safety of rivaroxaban (Xarelto, Janssen) for the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or with peripheral artery...
Mahmood Razavi and George Adams, the national co-principal unvestigators of Mercator MedSystem's DANCE trial, have each presented comprehensive 13-month data from the trial during late-breaking sessions at International Symposium on Endovascular Therapy (ISET; 4-8 February, Holywood, USA) and Leipzig...
Cardiovascular systems (CSI) presented six-month data from its LIBERTY 360 degrees post-market study in a presentation at the 29th International Symposium on Endovascular Therapy (ISET; 4-8 February, Hollywood, USA). The study is evaluating the acute and long-term clinical and...
Physicians in Japan have successfully treated the first 15 patients using Lombard’s new Intelliflex LP delivery system for the Aorfix endovascular stent graft since its launch on February 1, 2017. Intelliflex is used in conjunction with the Aorfix endovascular stent...
Profusa and North Carolina State University's ASSIST Center (Raleigh, USA) have announced that their collaboration to develop an ultrathin flexible-patch reader worn on the skin for continuous wireless monitoring of tissue oxygen in patients undergoing treatment for peripheral artery...
As the second year of enrolment draws to a close, the Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is well on its way to attaining its target enrolment. In the process, it...
In this interview, Vascular News speaks to Prakash Saha, King’s College Hospital, London, UK, about the growth of deep venous treatment and how the field can best address the ever-growing list of challenges. What are the challenges you face...
Veryan Medical has received a further £13.5m of funding in the form of both equity and debt from its existing investors, including Touchstone Innovations, Invesco Perpetual and Seroba Life Sciences. The debt element of the round has been provided...
QT Vascular has signed a definitive agreement with Medtronic, for the worldwide distribution of its Chocolate percutaneous transluminal angioplasty (PTA) catheter for a period of five years and automatically renewable for two additional one-year periods. The parties continue to...
High levels of moderate-to-vigorous physical activity are associated with lower arterial stiffness in six-to-eight year-old children, according to a new study from the University of Eastern Finland, Joensuu, Finland. No similar association was found for light physical activity. Published in...
The LUMINOR Registry is a real-world prospective multicentre study evaluating iVascular’s Luminor paclitaxel-eluting balloon for treating advanced limb ischaemia. Vascular News spoke to Vincent Riambau (Autonomous University of Barcelona, Barcelona, Spain), who presented an update on the Registry at...
The VasoStat (Forge Medical) is a haemostasis device designed for radial, brachial and transpedal procedures. The device is placed over the puncture site to achieve haemostasis by maintaining precise alignment over the