Tag: PAD

CIRSE 2019: Hear the latest from clinical trials comparing paclitaxel technologies...

NOTE: ONLY intended for healthcare professionals outside of the USA and France. Zoom in on a tête-à-tete between Marianne Brodmann (Graz, Austria) and Giovanni Torsello...

Statins linked with reduced mortality in PAD patients, even when started...

Statins are linked with reduced mortality in patients with peripheral arterial disease, even when started late after diagnosis, reports a study presented recently at...
SFDI

New study points to SFDI as promising technology for assessing patients...

New evidence supports the utility of spatial frequency domain imaging (SFDI) for identifying compromised circulation in patients at risk of peripheral arterial disease (PAD)....

CX 2019: Evidence supports safety of paclitaxel-coated devices

 At the Charing Cross International Symposium, Gary Ansel (Columbus, Ohio) moderates a global panel that includes Thomas Albrecht (Berlin, Germany), Peter Schneider (San Francisco,...

Depression and peripheral arterial disease: A call to action

With “an indisputable association between depression and peripheral arterial disease (PAD)”—nearly a third of PAD patients experience comorbid depression or depressive symptoms—Joel Ramirez and...

Customising therapy in femoropopliteal revascularisation

 Gary Ansel (Columbus, USA) tells Vascular News at VEITHSymposium 2018 about how drug-based therapies have become a mainstay in femoropopliteal revascularisation and how interventionalists...

Identifying and repairing dissections that matter

 Marianne Brodmann (Graz, Austria) quizzes Michael Lichternberg (Arnsberg, Germany) at LINC 2019 on his choice of tools to identify and repair dissections in both...
cigarette

Smoking cigarettes associated with increased risk of peripheral arterial disease in...

African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
cigarette

Smoking cigarettes associated with increased risk of peripheral arterial disease in...

African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...

PCSK9 inhibitors, rivaroxaban and a diabetes drug are major milestones in...

Michael Jaff (Newton, USA) outlines the major recent developments in best medical therapy that will impact the treatment of peripheral arterial disease (PAD) at...

Lutonix BTK IDE: First Level 1 evidence of positive safety and...

 Patrick Geraghty (St Louis, USA) presented new datapoints from the six-month outcomes of the Lutonix BTK IDE trial at the 2018 VEITHsymposium (13–17 November,...

Lutonix 014 DCB gathers first randomised evidence of positive safety and...

Six-month outcomes of the Lutonix BTK IDE trial, a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (DCB; BD), has demonstrated that...

Similar patency outcomes in women and men treated with Stellarex DCB

A study presented at VIVA 2018 (5–8 November, Las Vegas, USA) by Maureen Kohi, associate professor of Clinical Radiology, University of California, San Francisco,...

IN.PACT SFA Trial five-year data and Total IN.PACT All-Subjects analysis presented...

  The five-year and final results from the pivotal IN.PACT SFA Trial and one-year all-subjects results from the Total IN.PACT Pooled Analysis of the IN.PACT...

Consider intravascular lithotripsy when treating calcified femoropopliteal arteries

 Treating severely calcified arteries by endovascular means is still a challenge, although atherectomy, stents and lithotripsy are all techniques that are employed. Lithotripsy (also...

Eximo Medical receives FDA clearance for B-Laser atherectomy system to treat...

Eximo Medical has announced it has received 510(k) clearance from the US Food & Drug Administration (FDA) for its B-Laser atherectomy system for peripheral...

Peripheral arterial disease patients at increased risk for high opioid use

Patients with peripheral arterial disease (PAD) are found to have an increased risk for high opioid use. Nathan Itoga and colleagues from the University...

HART PAD blood test accurately diagnoses peripheral arterial disease in diabetic...

Prevencio has announced data demonstrating its HART PAD test accurately diagnoses peripheral arterial disease (PAD) in diabetes mellitus patients, a patient population in which...

First-ever CE mark of a bioresorbable scaffold for below-the-knee PAD

Reva Medical, a company developing bioresorbable polymer technologies for vascular applications, has announced that its Motiv bioresorbable scaffold is the first drug-eluting bioresorbable scaffold...

Ra Medical files statement for proposed initial public offering

Ra Medical Systems has filed a registration statement on Form S-1 with the US Securities and Exchange Commission relating to a proposed initial public...

Terumo gets CE mark for Kanshas drug-coated balloon catheter for lower...

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....

Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral...

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...

LIBERTY 360 18-month outcomes presented at CRT

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...

US FDA clears CorPath GRX system for use in peripheral vascular...

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...

LimFlow completes enrolment in US feasibility study

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....

LINC 2018 data highlight IN.PACT Admiral as safe and effective treatment...

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...

Hyperspectral imaging for assessing regional foot perfusion

There has been significant progress in limb salvage in patients with peripheral artery disease (PAD) and critical limb ischaemia (CLI) over the past two...

PAD catheter effective in all lesion types receives FDA clearance

XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the US Food and Drug Administration...

First patients treated with Avinger’s next generation atherectomy device

Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The...

PQ Bypass receives IDE approval to initiate pivotal DETOUR II clinical...

PQ Bypass has received conditional approval of its investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate the pivotal...
Janssen

Janssen submits application for new Xarelto (rivaroxaban) indications for CAD and...

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...
Xarelto

Xarelto (rivaroxaban) reduces risk of major amputation by 70% in peripheral...

Bayer and its cooperation partner Janssen Research & Development have announced two publications of further data from the Phase III COMPASS study in The...
Serranator Alto

Serranator PTA serration balloon catheter receives CE mark

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...

New Global Vascular Guidelines for chronic limb ischaemia to be published...

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)...

FDA 510(k) clearance for Nitiloop’s Nova Cross Extreme and Nova Cross...

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...

Mercator announces completion of enrolment in LIMBO-ATX

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...

First patient enrolled in IDE study of the Pantheris system for...

Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy...

Phase I/II SHIELD trial results with SB-030 in peripheral vascular disease...

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...
Marlene Grenon and Greg Zahner

Depression and peripheral artery disease: The intersectionality of mental and physical...

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...

Patient adherence, funding and physician interest remain barriers to supervised exercise...

The US Centers for Medicare and Medicaid Services (CMS) has determined that there is now sufficient evidence to cover supervised exercise therapy for the...

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...

New analysis suggests peripheral artery disease affects 42–60 million Chinese citizens

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...

Shockwave Medical reports positive results for Lithoplasty in calcified lesions below...

Shockwave Medical has reported positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe...

Luminor EffPAC study shows efficacy at six months

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...

Lesion preparation using Diamondback 360 orbital atherectomy enhances paclitaxel distribution in...

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...

Two-year efficacy of Philips’ Stellarex 0.035” low-dose drug-coated balloon demonstrated

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”...

Two- and four-year IN.PACT Admiral drug-coated balloon data indicate good mid-...

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...

New Mimics data support use of the BioMimics 3D swirling flow...

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,...

Contego Medical announces ENTRAP Study initiation for Vanguard IEP peripheral balloon...

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.PACT Admiral drug-coated balloon is approved in Japan

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...

Gardia Medical demonstrates enhanced safety in lower extremity interventions

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...

ESC publishes new guidelines on the diagnosis and treatment of peripheral...

European Society of Cardiology (ESC) Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, developed in collaboration with the European Society for Vascular...

Full US availability of Biotronik Pulsar-18 self-expanding stent announced

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...

Outpatient atherectomy outcomes may be “worse than the natural history of...

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...

Surmodics receives IDE approval to initiate SurVeil drug-coated balloon pivotal trial

Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the...

Spectranetics announces FDA approval of Stellarex drug-coated balloon

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...

Ra Medical Systems granted broad patent for DABRA catheter

The US Patent and Trademark Office has granted Ra Medical Systems a broad patent (number 9700655) that covers Ra Medical Systems’ DABRA catheter for...

IN.PACT Admiral approved for reimbursement in France and Belgium

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...

Cagent Vascular announces FDA 510(k) clearance of Serranator Alto serration balloon...

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...

Japanese IN.PACT SFA study demonstrates clinical outcomes consistent with other trials

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...

Cardiovascular Systems signs distribution agreement with Medikit for Japan

Cardiovascular Systems has signed an exclusive distribution agreement with Medikit to sell its Diamondback 360 Coronary and Peripheral Orbital Atherectomy Systems (OAS) in Japan. According to...

LEG-DEB registry reports encouraging six-month interim analysis for LegFlow

Six-month interim analysis of the Legflow drug-eluting balloon for the treatment of femoropopliteal occlusions (LEG-DEB) registry indicates that “the use of a new generation...

SUPERFAST results show advantage of Supera for chronic total occlusions

New data from a propensity matched prospective study suggest the Supera stent (Abbott Vascular) delivers superior results when compared to older generation nitinol stents...

Medtronic receives FDA clearance of new lower profile HawkOne 6F directional...

Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating...

Enrolment completed in the MIMICS-2 study

Veryan Medical has announced completion of patient enrolment in the MIMICS-2 clinical study of its BioMimics 3D self-expanding stent system (BioMimics 3D), which features...

Akesys and Elixir announce first human implant of the Prava bioresorbable...

Akesys Medical has announced their first clinical trial and successful implant of the Prava sirolimus-eluting bioresorbable peripheral scaffold system for the treatment of blockage...

Shockwave Medical Lithoplasty system is cleared by the FDA

Shockwave Medica has announced clearance from the US Food and Drug Administration (FDA) of the Lithoplasty system for the treatment of calcified plaque in...

First patient enrolled in the MIMICS-3D registry

Veryan Medical has announced that the first patient has been enrolled into the company-sponsored MIMICS-3D registry by Michael Lichtenberg, Arnsberg, Germany. MIMICS-3D is a...

EUCLID trial to analyse monotherapy of ticagrelor versus clopidogrel in patients...

Despite “overwhelming data” demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data for antiplatelet therapy for peripheral arterial disease (PAD) are...

Cardiovascular Systems releases 30-day results from LIBERTY 360° study

Cardiovascular Systems has released procedural and 30-day results from its LIBERTY 360° study in a late-breaking presentation at the 2016 Amputation Prevention Symposium (AMP;...

TOBA study results demonstrate 76.4% 12-month primary patency and 89.5% freedom...

The one-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty (TOBA) clinical study have been published in the Journal of Vascular Surgery. The TOBA study...

First randomised Stellarex DCB data show 12-month outcomes superior to percutaneous...

Marianne Brodmann of Medical University Graz, Austria, has presented the final 12-month results of the Stellarex (Spectranetics) ILLUMENATE drug-coated balloon European randomised clinical trial...

Gore Tigris vascular stent gains FDA approval for treatment of peripheral...

Gore has announced US Food and Drug Administration (FDA) approval of the Gore Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design....

REALITY trial enrols first patient in study evaluating Medtronic directional atherectomy...

Medtronic and VIVA Physicians reported on 27 July 2016 the first patient enrolled in the REALITY Study. The VIVA-sponsored study is assessing outcomes for...

UK NICE publishes Medtech Innovation Briefing on Lutonix

The UK National Institute for Health and Care Excellence (NICE) has developed a Medtech Innovation Briefing (MIB) on the Lutonix drug-coated balloon (DCB) for...

Promising findings for novel drug-eluting peripheral stent

A new animal study, presented at EuroPCR (17–20 May, Paris), indicates that a novel, fluoropolymer-coated, self-expanding, paclitaxel-eluting peripheral stent (Eluvia, Boston Scientific) is associated...