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Xarelto (rivaroxaban) reduces risk of major amputation by 70% in peripheral artery disease patients
Bayer and its cooperation partner Janssen Research & Development have announced two publications of further data from the Phase III COMPASS study in The...
Depression and peripheral artery disease: The intersectionality of mental and physical wellbeing
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...
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...
Ra Medical Systems receives US FDA clearance for DABRA peripheral artery disease treatment
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...
Consistent results for Medtronic IN.PACT Admiral in complex peripheral artery disease analyses
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...
Tigris stent gets Health Canada approval for peripheral artery disease
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...
Last patient enrolled in SB-030 SHIELD trial for peripheral artery disease interventions
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...
Study demonstrates sustained benefit of endovascular intervention in patients with lower extremity peripheral artery...
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...
US National Institutes of Health grant US$1.5m for peripheral artery disease oxygen monitor
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...
Shockwave Medical announces plans for “largest ever” calcified peripheral artery disease study
Shockwave Medical has announced plans for DISRUPT PAD III—what is claims is the “largest ever” multicentre randomised study to exclusively enrol patients with calcified...
Brilinta fails to demonstrate benefit over clopidogrel for peripheral artery disease patients in EUCLID...
AstraZeneca has announced that top-line results from the EUCLID trial indicate that Brilinta (ticagrelor) did not demonstrate a benefit over clopidogrel in a symptomatic...
The use of robotics in peripheral artery disease interventions
Despite significant advances in pharmacotherapy and device technology for percutaneous cardiovascular interventions, the fundamental technique of manually advancing intravascular devices at the patient’s table...
New SVS peripheral artery disease reporting standards announced
The Society for Vascular Surgery has released new reporting standards focused on endovascular treatment of chronic lower extremity peripheral artery disease. Recommended reporting standards...
CardioVascular Coalition urges increased awareness of peripheral artery disease in September
The CardioVascular Coalition (CVC)—a group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness,...
Gore Tigris vascular stent gains FDA approval for treatment of peripheral artery disease
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....
Edoxaban with aspirin may be a “paradigm shifting” treatment for peripheral artery disease patients...
Peripheral artery disease patients who undergo endovascular treatment may have a lower risk of major and life-threatening bleeding events and a lower risk or...
Supera stent offers effective cost-saving peripheral artery disease treatment for both payer and provider
The Supera peripheral stent offers the lowest risk of repeat procedures and is an “economically attractive” treatment for both payer and provider, according to...
Biotronik announces improved patient outcomes with combination therapy for peripheral artery disease
The 24-month results from the DEBAS clinical trial have been presented at the VEITHsymposium (17–21 November, New York, USA). Biotronik says that DEBAS is...
CE mark approval for Lithoplasty balloon catheters for the treatment of peripheral artery disease
Lithoplasty is a novel balloon-based technology that utilises integrated lithotripsy, a pulsatile mechanical energy commonly used to break up kidney stones, to disrupt both superficial and deep calcium and normalise vessel wall compliance prior to low-pressure balloon dilatation.
Medtronic drug-coated balloon for peripheral artery disease also benefits patients with diabetes
Medtronic's IN.PACT Admiral drug-coated balloon, used for the treatment of peripheral artery disease in leg arteries above the knee, provided a consistently favourable treatment effect in patients with diabetes in a landmark study of the investigational medical device, which is under review by the US Food and Drug Administration (FDA) for approval.
Therapy with GM-CSF fails to improve walking ability for patients with peripheral artery disease
In a study presented at the AHA Scientific Sessions and published online in JAMA, researchers have found that therapy with granulocyte-macrophage colony stimulating factor (GM-CSF) did not improve treadmill walking time at three months of follow-up.
Multicentre investigator-sponsored cell therapy study for peripheral artery disease approved in Japan
The study will investigate the use of patients' own adipose-derived stem and regenerative cells processed by the Celution System for peripheral artery disease or arteriosclerosis obliterans.
First US peripheral artery disease patient enrolled in CONNECT II trial
The CONNECT II global clinical trial is designed to evaluate the safety and efficacy of Ocelot (Avinger), the first-ever chronic total occlusion crossing catheter to use real-time intravascular optical coherence tomography imaging technology.
Vascular Magnetics raises financing to advance magnetically targeted drug delivery system for peripheral artery...
The Vascular Magnetic Intervention system delivers biodegradable, magnetic paclitaxel-loaded particles to the arterial wall. A clinical trial is expected to begin in 2014.
Cook Medical launches the Advance 18 PTX drug-eluting balloon dilatation catheter for peripheral artery...
The Advance 18 PTX combines the benefits of mechanical and drug therapies, taking advantage of the Advance balloon and the anti-proliferative effects of paclitaxel.
ESPRIT I clinical trial to study drug-eluting bioresorbable therapy in peripheral artery disease
The ESPRIT I clinical trial in Europe will evaluate the safety and performance of Abbott's Esprit drug-eluting bioresorbable vascular scaffold (BVS) in the treatment of blockages in the superficial femoral arteries and iliac arteries that result in claudication.
Exercise may be better than stents for patients with peripheral artery disease
Supervised exercise was shown to be more effective than stenting or medication for improved walking ability in patients with peripheral artery disease, results of the CLEVER study have shown.
Vermillion announces positive top-line results from blood test study to identify subjects at risk...
The intended use study was a prospective, double-blinded multicentre study of approximately 1,000 subjects who met specific inclusion criteria for being at increased risk of having peripheral artery disease, including smokers and diabetics age 50 or above and elderly age 70 or above.
Sedentary people are more likely to develop peripheral artery disease, study shows
Patients who reported no regular lifetime recreational activity had a 1.5 increased chance of having peripheral artery disease after corrected for other cardiovascular risk factors.
FDA approves the Gore Viabahn endoprosthesis to treat peripheral artery disease
The Gore Viabahn with heparin bioactive is the only stent-graft approved in the USA for use in the superficial femoral artery and iliac artery.
Women with peripheral artery disease lose ability to walk short distances and climb stairs...
These sex differences may be attributable to smaller baseline calf muscle area among women.
Published study demonstrates effectiveness of Turbo-Booster for peripheral artery disease
CELLO study demonstrated significant reduction in artery blockage following excimer laser ablation with Turbo-Booster with no major adverse events.
Study explains how exercise helps patients with peripheral artery disease
The findings of study conducted by researchers at Beth Israel Deaconess Medical Center, Boston, USA, demonstrate that a protein called PGC-1alpha plays a key role in the process.
Atlas on peripheral artery disease is launched in the US
The PAD Atlas, a database that maps the prevalence of the condition by zip code down to the street level, is available on www.mappad.org.
Strategies for lower extremity peripheral artery disease compared
Endovascular vs. open surgery, amputation rates included in study of Medicare patients published in the Journal of Vascular Surgery.
Seaweed and fireflies guide stem cell treatment for peripheral artery disease
Successful delivery of live, traceable stem cells for reconstitution of blood vessels is demonstrated in animal model
Rivaroxaban recommended by NICE for peripheral and coronary artery disease patients
The National Institute for Health and Care Excellence (NICE) in the UK has published a positive draft final appraisal determination recommending the use of...
Adding 8–12mm diameter devices to the Shockwave Peripheral Intravascular Lithotripsy toolkit
This advertorial is sponsored by Shockwave Medical.
Mazin Foteh, MD, contrasts the benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy Catheter alongside those...
Shockwave IVL: A paradigm shift in the treatment of common femoral artery lesions
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Raphaël Coscas (Ambroise Paré Hospital, AP-HP...
Humacyte publish six-year outcomes in study of HAV for peripheral arterial bypass
Humacyte, a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced...
Terumo announces study results underscoring safety and efficacy of radial to peripheral interventions in...
Terumo Medical Corporation has announced late-breaking data showing the safety and efficacy of radial to peripheral (R2P) interventions with the R2P Misago self-expanding peripheral...
Transit Scientific announces XO Cross success in CLTI pedal artery access
Transit Scientific has reported multiple successful peripheral vascular procedures with the XO Cross catheter platform utilising pedal retrograde access.
The non-tapered 2Fr XO Cross...
“No pain, no gain” approach improves walking ability with peripheral arterial disease
Walking for exercise at a pace that induced pain or discomfort improved walking ability among people with peripheral arterial disease (PAD), according to new research...
Cardiovascular Systems announces first in-human experience with peripheral everolimus DCB
Cardiovascular Systems Inc (CSI) has announced the start of enrolment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed...
Transit Scientific announces successful use of XO Cross platform in challenging peripheral vasculature
Transit Scientific recently announced that its XO Cross platform has been successfully used in challenging peripheral vascular procedures.
A press release details that Jihad Mustapha,...
Head-to-head trial shows superiority of FemoSeal over ProGlide for peripheral interventions
Results of the randomised, prospective, multicentre STEP trial show that the FemoSeal vascular closure system (Terumo) is superior to the Perclose ProGlide suture-mediated closure...
First patient enrolled in BIONETIC-I study of iliac artery treatment with Biotroniks’s Dynetic-35 stent...
Biotronik has announced the first patient enrolment in the BIONETIC-I study of the safety and efficacy of the Dynetic-35 cobalt chromium balloon-expandable stent system...
Episode 1: Go behind the scenes to delve into the birth and evolution of...
To mark the 20-year anniversary of drug-coated balloons, Bruno Scheller (Homburg/Saar, Germany) and Gunnar Tepe (Rosenheim, Germany), talk to Vascular News about their contributions...
REALITY study “sets new benchmark” for assessment of claudicants with severe femoropopliteal disease
Krishna Rocha-Singh (Springfield, USA) speaks to Vascular News about his presentation at VIVA20 (Vascular Interventional Advances; 6–7 November 2020; virtual) on the REALITY study,...
First patients enrolled in SUPERSURG study of Supera peripheral stent system
ID3 Medical Belgium has announced the first two enrolments in the SUPERSURG study to investigate the safety and efficacy of Abbott's Supera peripheral stent...
CX 2020 LIVE: Strong support for relining peripheral arteries and rivaroxaban use for widespread atherosclerosis
In a series of Podium 1st presentations from world-class faculty, CX 2020 LIVE attendees heard the latest data on peripheral arterial disease management and an evaluation of different types of stents, including...
Pedal artery revascularisation: Is it ready for prime time?
Reviewing the available evidence for below-the-ankle interventions in the treatment of critical limb-threatening ischaemia (CLTI), Srini Tummala proposes that pedal artery intervention “should be...
Teamwork prescribed to tackle major demographic trends in vascular disease
“Caring for vascular patients is going to take a team,” concluded Marc Bonaca (Boston, USA) at the 2019 Vascular Interventional Advances (VIVA) conference in...
VIVA 2019: CFA disease can be treated endovascularly with Supera stent
Two-year data confirm that common femoral artery (CFA) disease can be treated endovascularly with the Supera stent (Abbott). Results of the VMI-CFA study were...
First patient in Middle East treated with peripheral orbital atherectomy system from Cardiovascular Systems
The first patient in the United Arab Emirates has been treated with the Stealth 360 peripheral orbital atherectomy system (Cardiovascular Systems), intended for the...
Peripheral arterial disease risk hinges on health factors and demographics, including race
A recent study found that being a smoker, having diabetes, and also having a history of coronary heart disease or stroke increases the lifetime...
Biotronik expands peripheral portfolio with a new treatment tool for interventions in complex lesions
Biotronik has launched the Carnelian support catheter, designed to improve the access for treatment of tortuous and highly calcified lesions. Carnelian support is indicated...
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...
Smoking cigarettes associated with increased risk of peripheral arterial disease in African Americans
African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
Smoking cigarettes associated with increased risk of peripheral arterial disease in African Americans
African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
Eximo Medical receives FDA clearance for B-Laser atherectomy system to treat peripheral arterial disease
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...
Cardiovascular Systems announces launch of Peripheral Orbital Atherectomy System outside the USA
Cardiovascular Systems Inc. (CSI), a medical device company developing and commercialising interventional treatment systems for patients with peripheral and coronary artery disease, has announced...
HART PAD blood test accurately diagnoses peripheral arterial disease in diabetic patients
Prevencio has announced data demonstrating its HART PAD test accurately diagnoses peripheral arterial disease (PAD) in diabetes mellitus patients, a patient population in which...
Bayer announces new licensed indication for use of Xarelto in patients with coronary or...
Xarelto, co-administered with aspirin, is indicated in the EU for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or...
First US implants of MicroStent for peripheral arterial disease take place
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)...
XableCath granted US patent for its peripheral arterial catheters
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...
US FDA clears CorPath GRX system for use in peripheral vascular interventions
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...
First patients treated with new peripheral orbital atherectomy device
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...
LINC 2018 data highlight IN.PACT Admiral as safe and effective treatment option in peripheral...
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...
Particulate embolisation after femoral artery treatment with drug-coated balloons
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...
ACT 1 subgroup analysis shows benefit of carotid artery stenting for women and highly...
New ACT 1 subgroup analysis demonstrates that in female patients the rate of ipsilateral stroke is lower with carotid artery stenting (CAS) compared with...
Lesion preparation using Diamondback 360 orbital atherectomy enhances paclitaxel distribution in calcified peripheral arteries
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...
Contego Medical announces ENTRAP Study initiation for Vanguard IEP peripheral balloon angioplasty system with...
Contego Medical has announced the initiation of the ENTRAP Study evaluating usage of its Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection...
ESC publishes new guidelines on the diagnosis and treatment of peripheral arterial diseases
European Society of Cardiology (ESC) Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, developed in collaboration with the European Society for Vascular...
ESC 2017: Rivaroxaban significantly lowers risk of stroke, cardiovascular death, and myocardial infarction in...
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)...
Outpatient atherectomy outcomes may be “worse than natural history of disease”
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...
Contego Medical receives CE mark for Vanguard IEP peripheral balloon angioplasty system
Contego Medical has announced that it has received CE mark for its Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection. The company...
Achieving haemostasis in radial artery access
The VasoStat (Forge Medical) is a haemostasis device designed for radial, brachial and transpedal procedures. The device is placed over the puncture site to...
Improved renal function after renal artery stenting is associated with improved survival and fewer...
Further sub-group analysis of CORAL trial data indicates that retrieval of renal function after renal artery stenting improves survival and decreases cardiovascular and renal...
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...
Aspirin plus ticagrelor may reduce cardiovascular and limb events in peripheral arterial disease patients...
Data from the PEGASUS-TIMI 54 trial indicate that the use of aspirin plus ticagrelor (Brilinta, AstraZeneca) in patients with prior myocardial infarction and concomitant...
OrbusNeich expands into peripheral disease devices
OrbusNeich has expanded its portfolio to include products to treat peripheral artery disease. The JADE and Scoreflex PTA balloons are the company's first entry...
Shockwave Medical announces positive study results of Lithoplasty system for peripheral arterial disease
Shockwave Medical has announced positive clinical results from the pooled DISRUPT PAD Study, a single-arm, two-phase multicentre study evaluating the safety and performance of...
FDA clears CorPath robotic system for use in peripheral vascular intervention
The US Food and Drug Administration has cleared Corindus Vascular Robotics’ CorPath system for use in peripheral vascular interventions.
This is the third clearance for...
“We need to find the optimal stent configuration for venous disease”
Rick De Graaf, Department of Radiology, Maastricht University Medical Centre, Maastricht, The Netherlands, presented the results of the first comparative study of four dedicated...
Veryan Medical sets up German direct sales operation for BioMimics 3D peripheral self-expanding stent
Veryan Medical set up a direct sales operation in Germany through which it will sell its BioMimics 3D peripheral self-expanding stent system.
Chas Taylor,...
Medtronic IN.PACT Admiral DEB granted CE mark for treatment of AV access in patients...
The IN.PACT Admiral drug-eluting balloon (DEB) has been granted CE mark for arteriovenous (AV) access to help maintain haemodialysis access in patients with end-stage...
Spiral flow may be key to improving peripheral arterial stent performance
A review of haemodynamics in stent development, published in Annals of Biomedical Engineering, suggests that the re-introduction of spiral flow after endovascular treatment for...
New aortic and peripheral data from two late-breaking trials revealed by Medtronic
New clinical data in interventional treatments for aortic and peripheral vascular diseases have been revealed by Medtronic during a late-breaking trial session at Vascular...
REALITY study will evaluate use of directional atherectomy and drug-coated balloon in peripheral arterial...
Medtronic announced on 2 November 2015 the initiation of the REALITY Study (Directional atherectomy + drug-coated balloon to treat long, calcified femoropopliteal artery stenoses)...
Medtronic drug-coated balloon sustains superiority over balloon angioplasty at two years in patients with...
The IN.PACT Admiral drug-coated balloon (DCB) provides superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease...
Japan’s Zilver PTX two-year results support global evidence for drug-eluting stents in the superficial...
Kimihiko Kichikawa, Department of Radiology at Nara Medical University in Japan, reported two-year results of the Zilver PTX post-market surveillance study at CIRSE 2015.
FDA clears guidewire for Cardiovascular Systems’ peripheral orbital atherectomy systems
According to the company, the ViperWire advance peripheral guidewire with flex tip offers greater flexibility and navigation; improves systems' ease-of-use when treating calcified lesions in torturous arterial anatomy.
Spectranetics accelerates investment in Stellarex drug-coated balloon for below-the-knee disease
Below-the-knee market segment expected to grow to US$150m by 2020.
Cardiovascular Systems receives FDA clearance for new peripheral Diamondback device
Clearance expands company’s low-profile, minimally invasive product portfolio and broadens treatment options for patients and physicians.
EverFlex peripheral stent delivers sustained patency in long, complex lesions
Medtronic's EverFlex is a nitinol stent system that expands to a predetermined diameter to re-open stenotic regions of the superficial femoral artery and proximal popliteal arteries that supply blood to the legs.
Vascular Solutions launches PolarCath Peripheral Dilatation System
The PolarCath peripheral dilatation system is indicated for use in dilating stenoses in the peripheral vasculature and for the treatment of obstructive lesions of PTFE access grafts or arteriovenous dialysis fistulae.
Prot̩g̩ GPS stent receives FDA approval for the treatment of iliac artery stenosis
The news on the approval of the device from Medtronic follows the nine-month results of the DURABILITY Iliac study, which were presented in November 2014 and showed a 95.8% nine-month primary patency rate.
Covidien Stellarex drug-coated angioplasty balloon receives CE mark to treat peripheral arterial disease patients
The Stellarex drug-coated angioplasty balloon (Covidien) is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease.
Early results suggest Lithoplasty may be effective in the treatment of calcified peripheral lesions
Results of the DISRUPT PAD study show that Lithoplasty, a new balloon-based technology, demonstrates safety and efficacy in the treatment of superficial femoral artery and popliteal artery disease.
SCAI publishes expert consensus recommendations for treatment of renal artery stenosis
Renal artery stenting to open blockages in the kidney arteries may benefit patients who have historically been excluded from modern clinical trials, according to new recommendations e-published in Catheterization and Cardiovascular Interventions.
Medtronic expands availability of aortic and peripheral solutions to US market
Valiant Captivia thoracic stent graft system proximal FreeFlo tapers line extension now with dissection indication, and the TOTAL across crossing support catheter for peripheral artery disease in the below-the-knee vessel bed are now available to physicians in the United States.
Charing Cross 2014: Full three-day programme dedicated to peripheral arterial disease management
The programme dedicated to lower limb intervention will start with the peripheral arterial day in the Main Programme on Saturday and continue with the LINC @ CX peripheral intervention programme on Sunday and the CX ilegx Collaboration Day on Monday.
Renal denervation during surgery for aortic aneurysms and occlusive disease
By Juan Parodi
Hypertension is one of the most prevalent diseases in the world and represents a major cardiovascular risk factor. Sympathetic nerves of the...
Membrane alternative to ePTFE will be used for peripheral stents
According to DSM, developer of the new material, the UHMWPE membrane technology offers an alternative to current ePTFE film materials used for creating peripheral stents that treat peripheral artery disease.
Drug-eluting devices for the superficial femoral artery–why and when to treat?
While a large number of physicians are now convinced that drug elution represents a step forward from angioplasty and bare metal stenting in the...
DNA therapy and electroporation provides significant effects on peripheral arterial disease
A new application of Cellectra electroporation technology (Inovio) could dramatically enhance the ability of DNA therapy to stimulate blood vessel growth and recovery from debilitation caused by peripheral arterial disease and critical limb ischaemia.
Supera peripheral stent shows zero device fracture at 12 months
Clinical outcomes for 101 patients treated with the Supera peripheral stent system were published in the Journal of American College of Cardiology: Cardiovascular Interventions.
Spectranetics announces expansion into Japan peripheral intervention market
The company has received gulatory and reimbursement approval by Japan's Ministry of Health, Labour and Welfare for its Quick-Cross support catheter for peripheral interventions.
Is fractional flow reserve applicable to peripheral arteries as well as coronaries?
By Christopher K Zarins
The primary objective of treating an arterial stenosis is to improve blood flow. But how do we determine whether a lesion needs...
AngioScore launches new 100mm length AngioSculpt Scoring Balloons for treatment of peripheral arterial disease...
These catheters are expected to be particularly useful in treating complex lesions typically encountered in the treatment of patients with critical limb ischaemia and infra-popliteal peripheral arterial disease.
Final results of PATENT study support successful use of laser atherectomy for treating patients...
Data presented by Thomas Zeller at LINC indicate 82% and 52% freedom from target lesion revascularisation at six and 12 months, respectively, with procedural success rate at 98.9%.
First US Pulsar-18 stent implanted in BIOFLEX-I clinical trial for the treatment of peripheral...
The BIOFLEX-I study is a global, prospective, non-randomised, multicentre, investigational device exemption trial designed to evaluate the safety and efficacy of the Astron and Pulsar stent families (Biotronik) for the treatment of peripheral arterial disease.
Depression linked with increased risk of peripheral arterial disease
Depression was linked with an increased risk of peripheral arterial disease in a study of more than 1,000 men and women with heart disease conducted by researchers at the San Francisco VA Medical Center and the University of California, San Francisco, USA.
Can a new generation peripheral stent minimise thrombotic risk?
By Anna Maria Ierardi and Gianpaolo Carrafielo
Endovascular treatment for atherosclerotic obstructions in femoropopliteal arteries is widely used for patients with intermittent claudication and critical...
MOBILITY trial shows stent systems reduce adverse events and improve walking in patients with...
The MOBILITY trial was designed to test the effectiveness of the Absolute Pro Peripheral Self-Expanding Stent System and the Omnilink Elite Peripheral Balloon-Expandable Stent System (both from Abbott Vascular) in patients with intermittent claudication or critical limb ischaemia.
Abbott’s Absolute Pro Vascular Self-Expanding Stent System receives FDA approval for treatment of iliac...
The MOBILITY trial demonstrated Absolute Pro to be safe and effective in patients with peripheral artery disease in the lower extremities.
Medtronic joins Vascular Disease Foundation’s Corporate Roundtable
The Vascular Disease Foundation's Corporate Roundtable serves as a forum for dialogue between key industry representatives and most recognised thought leaders in the US vascular arena.
PATENT study shows positive results in treatment of in-stent restenosis in the femoropopliteal artery
Results from the PATENT (Photo-ablation using the Turbo-Booster and excimer laser for in-stent restenosis treatment) study presented at LINC 2012 in Leipzig, Germany, indicate 76% freedom from target lesion revascularisation at six months.
Vascular Disease Foundation recognises outstanding performance in the treatment of peripheral vascular diseases
Barry Katzen, Beth Murray, Anton N Sidawy, Manish Mehta, and two organisations: the American Association of CardioVascular and Pulmonary Rehabilitation and Center for Vascular Awareness were awarded at the Vascular Disease Foundation 8th annual meeting in Washington, USA.
CID launches new endovascular products for the treatment of peripheral vascular diseases
Nimble, a percutaneous transluminal angioplasty balloon and two self expandable peripheral stents, the Easy Flype and Easy HiFlype have been added to CID's endovascular products portfolio.
Biotronik announces completion of enrolment in the 4EVER study including long lesions in peripheral...
Secondary study focus is the potential for optimised results with Biotronik's novel 4F Solutions portfolio.
Cook Medical adds new sizes to its Zilver PTX drug-eluting peripheral stent system
The Zilver PTX is the world's only paclitaxel-eluting stent for diseased peripheral arteries.
Covidien reveals next generation EverFlex+ peripheral stent system
The new system is designed to reduce the risk of fracture when elongated, improving clinical outcomes for patients with peripheral arterial disease.
Eurocor launches peripheral drug-eluting balloon
The Freeway is the latest second-generation angioplasty balloon technology designed for the treatment of critical limb ischaemia associated with peripheral arterial disease.
AtheroMed announces launch of EASE clinical trial to evaluate peripheral arterial disease treatment
The company will enrol 90 patients as part of it EASE study to allow an evaluation of the safety and effectiveness of the Phoenix Atherectomy catheter.
Medtronic strengthens peripheral pipeline with Invatec buy
Medtronic's acquisition of Invatec will enable the company to arm its peripheral vascular product range and obtain four drug-eluting balloons, currently being hailed as one of the most promising interventional devices.
Abbott launches next-generation peripheral stent system in Europe
Omnilink Elite System incorporates Abbott's latest stent technologies, setting a new standard for performance and ease of use.
Invatec launches the Maris Plus self-expanding peripheral stent system at CIRSE
Greater visibility and flexibility for the treatment of peripheral arterial disease in the iliac region.
Abbott initiates trial for peripheral stent system
Abbott announces the initiation a clinical trial of the Absolute Pro peripheral self-expanding stent system in patients with iliac artery disease
Peripheral artery pain can be relieved by community exercise therapy
Study from The Netherlands found that intermittent claudication can be reduced through community supervised exercise therapy programs in regional physiotherapeutic practices.
What is the level of evidence for stenting in the superficial femoral artery?
Comments by Professor Johannes Lammer
Promising results for superficial femoral artery stenting
Results presented by Dr Martin Schillinger
Medtronic drug-coated balloon tops standard balloon angioplasty in landmark study
The study indicates that Medtronic's In.pact Admiral drug-coated balloon significantly outperformed standard balloon angioplasty in the treatment of symptomatic peripheral artery disease in the upper leg.
First drug-eluting balloon approved in USA
The FDA has approved the Lutonix drug-eluting balloon for the management of peripheral artery disease. This is the first time that the agency has approved such a device for this indication in the USA.
Avinger enrols first patient in VISION trial
VISION is a global investigational device exemption (IDE) clinical trial, approved by the FDA, to evaluate Avinger's Pantheris catheter for the treatment of peripheral artery disease.
CE mark for Ranger drug-coated balloon
The Ranger drug-coated balloon (Boston Scientific) provides physicians with an additional option to treat peripheral artery disease, delivering an anti-stenotic drug to diseased vascular tissue while leaving no permanent implant behind.
New 200mm length AngioSculpt scoring balloon catheters launched
AngioScore has launched its new 200mm length AngioSculpt PTA scoring balloon catheters for the treatment of peripheral artery disease above-the-knee.
Medtronic submits final data to FDA for In.Pact drug-coated balloon
The application includes data that demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularisation) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.
Volcano Corporation announces agreement to acquire AtheroMed
Volcano Corporation has announced that it has signed an agreement to acquire AtheroMed, a privately-held company that has developed the Phoenix Atherectomy System used in the treatment of peripheral artery disease.
FDA approves Supera stent
Abbott announced that its Supera peripheral stent system has received US Food and Drug Administration (FDA) approval to treat patients with blocked blood vessels in the upper leg caused by peripheral artery disease.
FDA clears Diamondback devices
Cardiovascular Systems has received FDA clearance for the low profile, 60cm Diamondback devices designed to expand the treatment of peripheral artery disease.
Spectranetics achieves statistical endpoints of EXCITE ISR adjunct analysis
The EXCITE ISR trial has demonstrated the safety and efficacy of laser atherectomy to treat in-stent restenosis in patients with peripheral artery disease.
First premarket approval module for In.pact Admiral drug-eluting balloon submitted to the FDA
The ongoing global clinical programme of In.pact drug-eluting balloons for the treatment of peripheral artery disease in the lower extremities includes 24 studies involving more than 4,200 patients at approximately 230 sites worldwide.
Bard launches the Love Your Limbs awareness campaign
New website www.LoveYourLimbs.com provides information about peripheral artery disease and critical limb ischaemia to patients and physicians in an effort to reduce amputations.
Cordis acquires Flexible Stenting Solutions
According to the company, the addition of Flexible Stenting Solutions' FlexStent provides Cordis with the opportunity to evolve the S.M.A.R.T. stent platform to address unmet needs in the treatment of peripheral artery disease.
CONNECT II clinical trial completes enrolment
Avinger has announced that it has successfully completed enrolment in its CONNECT II global clinical trial. A study focused on treatment of peripheral artery disease.
Impact of transfusion and postoperative nadir haemoglobin reported at SVS annual meeting
Authors of the study presented at the Vascular Annual Meeting in the USA believe restrictive transfusion strategy is justified in peripheral artery disease patients.
Intact Vascular gets CE mark approval for Tack-it Endovascular Stapler device
The Tack-it Endovascular Stapler device is designed to optimise peripheral angioplasty results for the treatment of peripheral artery disease.
FDA clears TriReme’s Chocolate PTA balloon catheter
Chocolate's design is intended to minimise vascular overstretch and thus reduces injury during angioplasty procedures in patients with peripheral artery disease.
FDA Advisory Committee gives unanimous recommendation approval for Zilver PTX
The Zilver PTX (Cook Medical), is a drug-eluting stent developed to treat peripheral artery disease in the superficial femoral artery.
FDA approves the Wildcat catheter for crossing chronic total occlusions
Results from the CONNECT trial demonstrated that Wildcat (Avinger) was able to cross 89.3% (efficacy) of chronic total occlusions in peripheral artery disease that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile.
Covidien begins DEFINITIVE AR study’s patient enrolment
The study will examine the effects of treating patients with peripheral artery disease by using Covidien's TurboHawk or SilverHawk plaque excision systems before the use of a drug-coated balloon.
Zilver PTX stent from Cook Medical gains CE mark
Approval represents a global landmark in effective peripheral intervention for treating peripheral artery disease.
Women and minorities under-represented in trials
These groups of patients are generally under-reported in trials for aortic aneurysms, carotid artery stenosis and peripheral artery disease, says study.
MedAlliance acquired by Cordis
MedAlliance has been acquired by Cordis for a 2022 investment of US$35 million and a 2023 upfront closing payment of US$200 million, together with...
Alucent Biomedical granted US FDA approval for clinical study
Alucent Biomedical has announced that the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a US clinical study of...
SCAI welcomes FDA decision to remove red flag for use of paclitaxel-coated devices in...
The president of the Society for Cardiovascular Angiography & Interventions (SCAI), George Dangas (Icahn School of Medicine at Mount Sinai, New York, USA), has...
Advance Serenity PTA balloon now available in more sizes and locations
As announced at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June, National Harbor, USA), the Advance Serenity hydrophilic percutaneous...
Black patients nearly 50% less likely to receive revascularisation for PAD
A new study from Keck Medicine at the University of Southern California (USC; Los Angeles, USA) has uncovered “significant racial disparities” in the diagnosis, treatment and outcomes of...
Human-tissue engineered blood vessels remain durable at six years in PAD patients, latest study...
Mid-term results from a phase II study of surgical bypass using the Human Acellular Vessel (HAV; Humacyte) demonstrated an overall secondary patency rate at...
SIRONA trial enrolment completed
Concept Medical has announced the successful completion of enrolment for the SIRONA randomised controlled trial (RCT) investigating the use of its Magic Touch PTA...
Truveta announces collaboration with Boston Scientific to advance post-procedure patient insights and help address...
Truveta announced a strategic collaborative agreement with Boston Scientific to improve long-term patient care and gain insights into healthcare disparities. Through this collaboration, Boston...
Merit Medical launches the Prelude Roadster guide sheath
Merit Medical Systems has announced the US commercial release of the Prelude Roadster guide sheath. The Prelude Roadster is the newest addition to the...
First patient enrolled in SELUTION SLR IDE BTK study
The first patient has been enrolled in the US Food and Drug Administration (FDA) investigational device exemption (IDE) below-the-knee (BTK) SELUTION4BTK clinical trial involving...
FDA grants IDE approval for Selution SLR drug-eluting balloon
MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the US Food and Drug Administration, making it the first...
Vascular News’ top 10 most popular stories of April 2022
April's top 10 most popular stories include US Food and Drug Administration (FDA) approval of a frozen elephant trunk (FET) device, as well as...
Alucent Biomedical anounces first patient enrolled in first-in-human natural vascular scaffolding clinical trial
Alucent Biomedical announced in a press release that it has enrolled the first patient in ACTIVATE II, an Australia-based first-in-human clinical trial to evaluate...
New Janssen initiative aims to advance equitable care and address hidden threat of amputation...
Janssen has announced the launch of 'Save Legs. Change Lives. Spot Peripheral Artery Disease Now', a multi-year initiative aimed at creating urgency and action...
Regio Biosciences enters into license agreement with AstraZeneca for phase 2a asset in PAD
Regio Biosciences, a Hibiscus BioVentures company, recently announced it has entered into an exclusive license agreement with AstraZeneca to further develop REG-101, a novel therapeutic acting...
Soundbite Medical gains fifth US patent for its plaque modification technology
Soundbite Medical Solutions has announced that the US Patent and Trademark Office has issued a patent to a device for delivering high amplitude broadband...
Lower-dose SurVeil DCB achieves non-inferiority with IN.PACT Admiral balloon
Kenneth Rosenfield (Boston, USA) speaks to Vascular News about the TRANSCEND trial, a non-inferiority randomised controlled trial, which looked to demonstrate safety and efficacy of the...
First two patients enrolled in PRISTINE study with Selution SLR
MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with Selution sustained limus release (SLR) 018 drug-eluting balloon (DEB) for...
Vascular surgeons encouraged to consult talking points document on paclitaxel devices
Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has developed...
Surmodics’ Pounce thrombus retrieval system gains FDA 510(k) clearance
Surmodics has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Pounce thrombus retrieval system.
The company describes the Pounce system...
PRIZER, new multicentre PAD study, launches
A new post-market study investigating the effectiveness of the Renzan peripheral stent system (Terumo) in patients with peripheral arterial disease (PAD) has been...
SVS International Lecture: Endovascular pioneer discusses new PAD therapy
A new therapy of hydration and oncotic pressure of plasma helped 100% of certain elderly peripheral artery disease (PAD) patients in terms of pain,...
PCR e-Course 2020: Sirolimus-eluting balloon is a valid treatment for vasculogenic erectile dysfunction
A sirolimus-eluting balloon has been shown to be effective and safe for the treatment of vasculogenic erectile dysfunction (ED) in a first-in-man study presented...
Advance Serenity hydrophilic PTA balloon catheter now available in the USA
Cook Medical recently announced that the Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter is now available to physicians in the USA. The...
Surmodics receives CE mark for its SurVeil drug-coated balloon
Surmodics recently announced it has received CE mark certification in the European Union for its SurVeil drug-coated balloon (DCB).
“I am excited about the potential...
BD announces launch of Halo One thin-walled guiding sheath
BD has announced the launch of the Halo One thin-walled guiding sheath, designed to perform as both a guiding sheath and an introducer sheath,...
Cook Medical and Surmodics reach distribution agreement for two new vascular products
Cook Medical and Surmodics have announced an agreement in which Cook Medical will distribute two new Surmodics products, hydrophilic percutaneous transluminal angioplasty (PTA) balloon...
US podiatrists outline triage system and community care focus to combat COVID-19
“Our goal is to reduce the burden on the healthcare system by keeping patients safe, functional, and at home during the COVID-19 pandemic,” state...
Real-time tissue perfusion device can assess re-establishment of blood flow to foot microcirculation
Paul Hayes (Cambridge, UK) talks to BLearning Wounds at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about the challenges of wound...
Profusa wins CE mark approval for real-time tissue oxygen monitoring platform
Profusa has announced that it has received Conformité Européenne (CE) mark approval to market its Wireless Lumee Oxygen platform for continuous, real-time monitoring of...
First CLTI patient enrolled in PROMISE II pivotal study of LimFlow system
LimFlow, a specialist in minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), has announced...
Insera announces first-in-human treatment of patient with PE using CLEAR aspiration system
Insera Therapeutics announced recently that the first patient with acute pulmonary embolism has been treated with its flagship cyclical aspiration system, CLEAR. Earlier last...
Data show Zilver PTX leads to fewer complications and shorter hospital stays than traditional...
At this year’s VEITHsymposium (19–23 November, New York, USA), Marc Bosiers presented data that show that patient treatment with the Zilver PTX stent has...
VIVA 2019: ABSORB BVS achieves “excellent” long-term patency and freedom from TLR in the...
Ramon Varcoe today announced positive five-year results of the ABSORB BTK trial at the 2019 Vascular Interventional Advances conference (VIVA) in Las Vegas, USA...
VIVA 2019: Boston Scientific announces positive data for the Ranger DCB and the Eluvia...
Boston Scientific today announced positive data for two devices within the peripheral drug-eluting product portfolio during separate late-breaking clinical trial presentations at the 2019...
VIVA 2019: Four-year data from the IN.PACT Global study highlight durable performance and safety...
Medtronic today announced four-year data from the IN.PACT Global study, which reinforce the long-term durability and safety of the IN.PACT Admiral drug-coated balloon (DCB)...
Shockwave announces commercial availability of below-the-knew IVL catheter
Shockwave Medical today announced commercial availability of the Shockwave S4 peripheral intravascular lithotripsy (IVL) catheter in select approved geographies. Shockwave S4 is a low-profile...
Positive NICE recommendation for Xarelto to prevent atherothrombotic events in CAD and PAD patients
The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) recommending the use of Xarelto (rivaroxaban) by the...
Philips receives FDA approval for low-dose drug-coated balloons
Philips has received US Food and Drug Administration (FDA) approval for two Stellarex 0.035” low-dose (200mm and 150mm) drug-coated balloons for the treatment of...
TORUS SFA stent graft pivotal study granted unconditional IDE approval
PQ Bypass recently announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel...
AngioDynamics acquires Eximo Medical and its 355nm laser atherectomy technology
According to a press release, AngioDynamics has acquired Eximo Medical and its proprietary 355nm wavelength laser-technology platform for US$46 million in up-front consideration with...
Orchestra BioMed announce FDA breakthrough device designation for Virtue sirolimus-eluting balloon
Orchestra BioMed, in partnership with Terumo Corporation, today announced that the company has secured breakthrough device designation by the US Food and Drug Administration...
Proximo Medical named commercialisation partner for Biotronik’s PVI portfolio in select US markets
According to a press release, Proximo Medical has been announced as the commercial partner for Biotronik's peripheral vascular intervention (PVI) platform in select US markets.
Proximo Medical is...
Surmodics completes enrolment in pivotal TRANSCEND clinical trial
Surmodics has completed enrolment in TRANSCEND, its pivotal clinical trial for the SurVeil drug-coated balloon (DCB).
“TRANSCEND is a rigorous level one, randomised controlled trial...
Medtronic statement regarding updated FDA letter to healthcare providers on paclitaxel devices to treat...
Medtronic has issued the following statement regarding the US Food and Drug Administration’s (FDA) updated letter to healthcare providers for paclitaxel-devices in patients with...
Ra Medical clinical study aims to show DABRA keeps arteries healthy longer
Ra Medical is conducting a study to demonstrate the DABRA Excimer Laser System delivers effective, long lasting results and a low reintervention rate for...
Virtue sirolimus-eluting balloon set for commercial release as Terumo and Orchestra BioMed enter global...
Orchestra BioMed and Terumo have formed a global strategic partnership for the development and commercialisation of Virtue sirolimus-eluting balloon (SEB) in the percutaneous coronary...
Cardiovascular Systems announces first patient enrolled in REACH PVI clinical study
Cardiovascular Systems recently announced that the first patient has been enrolled in the REACH PVI study. The purpose of this study is to prospectively...
Cardiovascular Systems announces first patient enrolled in REACH PVI clinical study
Cardiovascular Systems recently announced that the first patient has been enrolled in the REACH PVI study. The purpose of this study is to prospectively...
Only Eluvia Uses a Polymer for Controlled, Targeted Delivery of the Lowest Drug Dose
Eluvia DES is the only technology that uses polymer-based drug delivery to treat Peripheral Artery Disease (PAD). Its polymer ensures that the majority of...
John Fletcher named strategic advisor to Micro Medical Solutions
Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that John Fletcher...
Cook Medical releases patient-level data from Zilver PTX paclitaxel-eluting stent study
Cook Medical has released de-identifiable patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent.
The move comes a month after the...
Positive outcomes of Eluvia drug-eluting stent in IMPERIAL sub-analyses
Boston Scientific has announced results from sub-analyses of the IMPERIAL clinical trial for the Eluvia Drug-Eluting Vascular Stent System at the 41st Charing Cross...
Reflow Medical completes enrolment in the Wing-IT IDE CTO clinical trial
Reflow Medical has announced the completion of enrolment in its Wing-IT investigational device exemption (IDE) trial; a prospective, multicentre, nonrandomised study evaluating the ability...
Lumee platform demonstrates successful oxygen monitoring in CLI patients
Profusa has announced promising clinical data from two studies evaluating the company's Lumee Oxygen Platform, a tiny, injectable tissue-integrated biosensor and an intelligent data...
Positive outcomes for Eluvia stent in long lesion IMPERIAL sub-study
Clinical outcomes from the IMPERIAL Long Lesion Sub-study were presented at VIVA (5–8 November, Las Vegas, USA) demonstrating that the Eluvia drug-eluting vascular stent...
Cook Medical receives FDA approval for first 5mm diameter SFA drug-eluting stent
Cook Medical have announced that a new 5mm diameter version of Zilver PTX was approved by the US Food and Drug Administration (FDA). It...
Avinger announces 510(k) filing of Pantheris Small Vessel device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the Company submitted a new 510(k) application to the US Food &...
An intermittent claudication meta-analysis: Findings point to sustained improvements after home use device treatment
Temple University’s systematic review and meta-analysis on eight independent intermittent claudication studies using pneumatic compression pumps has shown significant improvements in walking distances even...
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...
Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral drug-coated balloons
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...
Avinger’s next-generation Pantheris Lumivascular atherectomy system gets FDA clearance
Avinger has announced that the company received 510(k) clearance from the US Food & Drug Administration (FDA) for its next generation Pantheris Lumivascular atherectomy...
Med Alliance raises US$37 million to launch sirolimus drug-coated balloon
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...
Surmodics acquires thrombectomy technology assets from Embolitech
Surmodics, a provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has reached an agreement with Embolitech to...
IN.PACT Admiral DCB receives FDA approval for long SFA lesions
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...
The value of Swirling Flow and the BioMimics 3D clinical study programme
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...
New CMS reimbursement code “severely underpays” for drug-coated balloons
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...
Enrolment commences for Wing-IT IDE clinical trial of Wingman catheter
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)...
New data indicate AI-powered blood test accurately diagnoses aortic stenosis
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...
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...
Surmodics partners with Abbott to develop their next-generation DCB
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...
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...
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 trial
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 submits application for new Xarelto (rivaroxaban) indications for CAD and PAD patients
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...
TOBA single-centre trial shows 24-month patency rate of 87.5%
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...
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...
First patient enrolled in TRANSCEND trial for SurVeil DCB
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...
Patient adherence, funding and physician interest remain barriers to supervised exercise therapy
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...
Shockwave Medical reports positive results for Lithoplasty in calcified lesions below the knee
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...
Surmodics announces global approvals of 0.014” low-profile PTA balloon dilation catheter
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...
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”...
Encouraging 100% primary patency and improved quality-of-life scores at six months for SurVeil DCB
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...
PQ Bypass reports positive results for Detour system in patients with long femoropopliteal blockages
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)...
Two- and four-year IN.PACT Admiral drug-coated balloon data indicate good mid- and long-term safety...
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 stent in primary...
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,...
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...
CMS drug-coated balloon reimbursement code to expire in December
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...
Vonapanitase associated with increased fistula survival and haemodialysis use
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...
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...
Philips completes acquisition of Spectranetics
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...
Lasting benefits following endovascular intervention in critical limb ischaemia
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...
LIBERTY 360 degrees sub-analysis shows high freedom from adverse events with orbital artherectomy
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...
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...
Ra Medical Systems names Maurice Buchbinder and Martin Colombatto to board of directors
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...
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 speciality...
Philips to acquire Spectranetics
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...
First commercial use of Ra Medical Systems’ DABRA takes place in USA
The Heart Endovascular & Rhythm of Texas announced its latest collaboration with Ra Medical Systems to use the Destruction of Arteriosclerotic Blockages by laser...
Shockwave Medical Lithoplasty system launched in USA as first patient enrolled in DISRUPT PAD...
Shockwave Medical has announced two milestones for its Lithoplasty system for the treatment of calcified plaque in patients with peripheral artery disease (PAD): enrolment...
Surgery-first approach for CLI offers faster wound healing rate than endovascular treatment
A surgical-first strategy appears to be superior to endovascular treatment for critical limb ischaemia (CLI) revascularisation, exhibiting improved wound healing rate and overall healing...
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...
First patient enrolled in study of Medtronic IN.PACT arteriovenous access drug-coated balloon
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...
First US patient treated in vascular study of Shockwave Medical Lithoplasty technology
PinnacleHealth CardioVascular Institute has enrolled the first US patient in a trial assessing the safety and effectiveness of a new type of approach for...
Intact Vascular completes enrolment in TOBA II clinical trial
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...
Smartphone over treadmill: Mapping claudication with Google Maps
The use of GPS mapping tools has become a cornerstone of modern life. A study published by the Journal of Vascular Surgery has demonstrated...
PQ Bypass announces CE mark for Detour percutaneous bypass technologies
PQ Bypass has announced CE mark approval for a trio of proprietary devices: the Torus stent graft system, PQ Snare, and PQ Crossing Device,...
Eyes may hold clues to future narrowing of leg vessels
Changes in tiny blood vessels of the eye may predict a higher risk of later narrowing in the large blood vessels in the legs,...
Medtronic launches European below-the-knee clinical study of drug-coated balloon
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...
CMS close to reimbursing supervised exercise therapy to treat PAD in the USA
The US Centers for Medicare & Medicaid Services (CMS) have released the proposed decision memo for the approval of supervised exercise therapy for the...
Global cohorts report drug-coated balloon success above the knee and “promising” results below the...
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...
North Dallas Research Associates begin enrolling TOBA II BTK patients
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...
Cagent Vascular announces FDA 510(k) clearance of Serranator Alto serration balloon catheter
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...
Micro Medical Solutions receives CE mark for MicroStent
Micro Medical Solutions (MMS) has received CE mark approval for MicroStent, allowing the company to market this technology in Europe. MicroStent is a vascular...
Medtronic announces Health Canada licence for IN.PACT Admiral drug-coated balloon
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...
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...
COMPASS study of Janssen’s rivaroxaban to end early for efficacy
The phase three COMPASS trial, evaluating the efficacy and safety of rivaroxaban (Xarelto, Janssen) for the prevention of major adverse cardiac events, including cardiovascular...
TVA Medical presents positive everlinQ endoAVF system results at LINC 2017
TVA Medical has provided clinical updates involving its everlinQ endoAVF system at the 2017 Leipzig Interventional Course (LINC; 24-17 January, Leipzig, Germany).
Scientific data regarding the...
US FDA grants Medtronic investigational device exemption for IN.PACT Admiral AV fistula study
Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a study of the IN.PACT Admiral...
Medtronic receives CE mark for lower-profile HawkOne directional atherectomy system
Medtronic has been granted CE mark approval for the HawkOne directional atherectomy system in a lower profile size for treating patients with peripheral artery...
Intact Vascular closes on additional funding to advance development of Tack endovascular system
Current Intact Vascular investors—New Enterprise Associates, Quaker Partners and HIG BioHealth Partners—have exercised their right to invest additional capital as part of the company’s...
Humacyte commences US phase II arterial bypass clinical trial
Humacyte has announced the initiation of a US phase II arterial bypass clinical trial of Humacyl, an investigational human acellular vessel, to test its safety...
Avinger announces new FDA clearance for Lumivascular imaging console
Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lightbox L250 imaging console. Avinger says that with this...
SVS and SVM to launch vascular medicine registry
A new vascular medicine registry will be launched in early 2017 by the Society for Vascular Surgery (SVS) and the Society for Vascular Medicine...
Shockwave Medical raises US$45 Million in Series C financing to advance lithoplasty treatment for...
Shockwave Medical has announced the closing of US$45 million in Series C financing led by Sectoral Asset Management, with participation from mutual funds advised...
TIGRIS trial finds no stent fractures and positive primary patency in long lesions at...
Twenty-four month TIGRIS trial follow-up data show that treatment using the Tigris nitinol stent (Gore) for long lesions in the superficial femoral and popliteal...
Current status on drug-eluting devices in dialysis access
Dialysis access fistulae and grafts are life-saving in patients with renal insufficiency and failure. Numbers of patients requiring haemodialysis have continued to rise over...
Spectranetics files FDA pre-market approval application for the Stellarex drug-coated balloon
Spectranetics has submitted its pre-market approval application for the Stellarex drug-coated angioplasty balloon to the US Food and Drug Administration (FDA). Stellarex is designed to restore...
FDA approves TOBA II BTK pivotal IDE clinical study
The US Food and Drug Administration (FDA) has granted staged approval for Intact Vascular’s investigational device exemption (IDE) application to begin its TOBA II BTK...
Avinger launches upgraded Lightbox imaging console
Avinger has announced the US launch of an enhanced version of the company’s Lightbox imaging console. The Lightbox provides a dual display of images...
Medtronic receives FDA clearance of new lower profile HawkOne 6F directional atherectomy system
Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating...
Avinger granted expanded US FDA indications for Pantheris image-guided atherectomy device
Avinger has received expanded indications from the US Food and Drug Administration (FDA) recognising the Pantheris lumivascular atherectomy system as a technology that can be...
Lutonix Global Real-World Registry 24-month outcomes presented at VIVA 2016
Bard has announced the presentation of the final 24-month results from the Lutonix Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 meeting...
Six-month Shockwave Medical Disrupt PAD data show “consistent and predictable” procedural success
Shockwave Medical has announced positive clinical results from the pooled DISRUPT PAD Study, a single-arm, two-phase, multicentre study evaluating the safety and performance of...
FDA approves six-month primary endpoint for the Lutonix below-the-knee drug-coated balloon
The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint to a six-month...
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...
US FDA approves first drug-coated balloon for treatment of in-stent restenosis
The US Food and Drug Administration (FDA) has approved Medtronic’s IN.PACT Admiral drug-coated balloon as a treatment for in-stent restenosis in patients with peripheral...
Absorb bioresorbable scaffold yields 96% primary patency and freedom from reintervention below the knee...
Twelve-month follow-up of the everolimus-eluting, Absorb bioresorbable vascular scaffold (Abbott Vascular) below the knee has demonstrated “excellent safety, patency, and freedom from target lesion...
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 from TLR
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...
REALITY trial enrols first patient in study evaluating Medtronic directional atherectomy and DCB
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...
New report concludes endovascular procedures performed in office-based facilities result in positive outcomes
The CardioVascular Coalition (CVC)—a group of community-based endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and...
VentureMed announces FDA approval of Flex scoring catheter
VentureMed has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the Flex scoring catheter, an endovascular device that precisely and...
Good day for drug-coated balloons, swirling flow stents and drug-eluting stents at CX 2016
The CX Peripheral Arterial Challenges session at the 2016 Charing Cross Symposium (CX 2016; 25–29 April, London, UK) saw a host of new developments...
New IN.PACT Admiral data reinforce efficacy in females, chronic total occlusions and patients with...
Medtronic has announced with several new presentations that showed durable and consistent clinical outcomes in the most challenging patients with peripheral artery disease. The...
First patient enrolled in SurModics IDE study of SurVeil drug-coated balloon
SurModics has announced enrolment of the first patient in an early feasibility study of its proprietary SurVeil drug-coated balloon (DCB). A press release states...
Boston Scientific receives CE mark for Eluvia drug-eluting stent, begins IMPERIAL trial
Boston Scientific has received CE mark for the Eluvia drug-eluting vascular stent. It is to begin commercialisation of the product immediately in countries which...
The “egg” and the “brain” offer alternative to ankle brachial index measurement
BlueDop (BlueDop Medical) is a wireless egg-shaped device that converts a Doppler signal to a readable pressure measurement. Vascular News spoke to its inventor...
Real-world comparison shows similar efficacy between Bard Lutonix and Medtronic IN.PACT drug-coated balloons
Results presented at LINC 2016 revealed no significant difference at 18 months in target lesion revascularisation and sustained clinical improvement between the Lutonix and the IN.PACT drug-coated balloons. Clinical improvement was measured by improvement in Rutherford class from baseline or prior to drug-coated balloon treatment.
Medtronic to manufacture IN.PACT Admiral drug-coated balloon at new high-tech facility
Medtronic will manufacture the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD) at a new facility in Galway, Ireland.
According...
Cardiovascular Systems enrols first patients in OPTIMIZE study
The first two patients have been enrolled in Cardiovascular Systems’ OPTIMIZE peripheral orbital atherectomy system study. Taking place in Europe, OPTIMIZE will evaluate the...
Medtronic to unveil new clinical data at TCT
Medtronic has announced a preview of notable clinical studies that will be presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium (11–15 October, San...
Intact Vascular announces conditional FDA approval for TOBA II study and enrolment of first...
The US Food and Drug Administration has granted conditional approval for a US and European Investigational Device Exemption (IDE) clinical trial to investigate the...
Boston Scientific gains FDA approval of Innova vascular self-expanding stent system
The company has now commenced a full commercial launch of the treatment option for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery.
Global vascular thought leaders document shift toward individualising patient care in surgical bypass
Gore is making available an educational compendium of presentations and discussions from the inaugural Gore-sponsored Surgical Bypass Summit to promote knowledge sharing around this topic.
Intact Vascular secures US$38.9 million financing to accelerate development and approval of the Tack...
The Tack device is an endovascular method for repairing arterial dissections following angioplasty and permits highly targeted repair of diseased arteries, while minimising the metal left behind.
Medicare approves pass-through payment for Lutonix drug-coated balloon for outpatient use
The purpose of the supplemental reimbursement is to cover additional cost to US hospitals for treating Medicare beneficiaries with Lutonix in the outpatient setting.
Medicare approves transitional pass-through payment for outpatient use of Medtronic drug-coated balloon
Decision provides supplemental reimbursement to US hospitals for new medical device with potential to improve standard of care for peripheral arterial disease in upper leg.
Boston Scientific and Bard announce distribution agreement for Lutonix
Agreement extends reach of Lutonix drug-coated balloon to prepare and treat diseased femoropopliteal vessels.
IN.PACT Admiral drug-eluting balloon receives FDA approval
In the IN.PACT SFA trial, the device demonstrated the lowest clinically-driven target lesion revascularisation rate (2.4%) ever reported for an interventional treatment of peripheral arterial disease in the superficial femoral artery.
BIOTRONIK announces first implant in global BIOLUX P-III all-comers registry
The purpose of this prospective, multi-centre study is to collect and assess safety and efficacy data on the Passeo-18 Lux drug-releasing balloon for the treatment of obstructive disease of the infrainguinal arteries.
First European patients enrolled in QT Vascular’s ENDURE trial
QT Vascular has announced that it has enrolled the first European patients in the ENDURE trial in Germany. Multiple patients have already been enrolled in this study by Andrew Holden, Auckland, New Zealand.
TRUTH study demonstrates orbital atherectomy’s effectiveness at reducing and modifying calcified lesions with low...
TRUTH evaluated the removal of plaque with Cardiovascular Systems' Peripheral Orbital Atherectomy System by analysing changes in plaque volume and composition via an independent virtual histology (VH) - intravascular ultrasound (IVUS) core laboratory.
Biotronik announces completion of enrolment in SFA arm of BIOFLEX-I study
A total of 296 patients were successfully implanted with the Astron Pulsar and Pulsar-18 stents at 34 centres in the USA, Canada and Europe.
EXCITE trial data demonstrate acute, superior procedural success
The Excimer laser randomised controlled study for treatment of femoropopliteal in-stent restenosis (EXCITE ISR) showed a 93.5% procedural success rate with laser atherectomy plus percutaneous transluminal angioplasty for the treatment of in-stent restenosis versus 82.7% with percutaneous transluminal angioplasty alone.
Abbott completes acquisition of IDEV Technologies
The acquisition expands Abbott's global peripheral technology portfolio with IDEV Technologies' Supera Veritas self-expanding nitinol stent system, which has the CE mark for treating peripheral arterial disease.
Medtronic drug-eluting balloon study completes enrolment
The IN.PACT SFA II trial enrolled 181 patients at more than 40 US sites and randomised them 2:1 to the IN.PACT Admiral drug-eluting balloon or a non-coated angioplasty balloon.
Stem cell mobilisation shows trend in improving major amputation rate in critical limb ischaemia...
At 12 months, the major amputation rate in the STEMPAD study was 50% for patients treated with mobilisation therapy and 83.3% for patients in the control group.
First successful below-the-knee procedures with the Proteus device performed in the USA
Proteus (Angioslide) is used to treat high-risk diabetic and critical limb ischaemia patients. The system combines the functionality of a balloon angioplasty device with the addition of capture and removal of particles released during intervention.
Angioslide announces FDA 510(k) clearance of Proteus below-the-knee device
The new 3/100mm device accommodates 0.014" guidewires, which significantly broadens the potential use of Proteus technology, according to the company.
UH Case Medical Center enrols first patient in LEVANT 2 trial
LEVANT 2 will investigate whether the Moxy drug-coated balloon (Lutonix) is more effective than standard angioplasty at keeping leg arteries open and free from re-blockage over time.
Two live Ocelot cases to be performed at LINC in Germany
Ocelot (Avinger) is the first real-time optical coherence guided crossing catheter for chronic total occlusions in the peripheral vascular system.
AngioScore launches 100mm AngioSculpt balloon catheters
The devices have received FDA 510(k) clearance for the dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, as well as for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Boston Scientific launches Coyote balloon catheter
The Coyote balloon catheter is a highly deliverable and ultra-low profile 0.014 inch balloon dilatation catheter designed to treat patients undergoing peripheral angioplasty procedures below the knee.
TASC guidelines set to recommend “endovascular first” for all lesions
The new guidelines are set to recommend an endovascular first strategy, even for TASC D lesions. However, TASC IIb remains unpublished as vascular surgical societies have so far failed to endorse these recommendations. A criticism levelled at TASC has been the "fundamentally flawed" decision to change the lesion categorisation repeatedly, which was described as "shifting the goalposts"
Gore reports first patient treated in the USA using Gore Viabahn Endoprosthesis with heparin...
The first procedure was performed by Tony Das, director of Peripheral Interventions, Texas Health Presbyterian Hospital Dallas, Texas, USA.
Fusion Bioline vascular graft gets CE mark
Unlike traditional vascular grafts that utilise a single material, the Fusion Bioline is constructed of two layers, this unique construction delivers patient benefits such as: high suture retention strength and durability for long-term performance and minimal suture hole bleeding for improved haemostasis.
Boston Scientific acquires two devices to treat CTOs
A re-entry catheter from S.I. Therapies and an intraluminal CTO crossing device from ReVascular Therapeutics are Boston new acquisitions for the treatment of peripheral chronic total occlusions (CTOs).
Gore announces European availability of next generation of the Viabahn endoprosthesis
The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating lower limb stenosis and occlusions.
First patient enrolled in CONNECT clinical trial
Avinger has announced the enrolment of the first patient in the CONNECT (Chronic total occlusion crossing with the WildCat Catheter) clinical trial.
Maquet announces first patient enrolled in clinical trial of Fusion vascular grafts
The first patient was enrolled by Wei Zhou at VA Palo Alto Health Care System in Palo Alto, USA.
FDA approves Boston Scientific’s Express LD Iliac Stent System
The Company plans to launch the first and only premounted, balloon-expandable stent approved specifically for use in iliac arteries immediately in the USA.
Cordis launches Aquatrack
Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, recently announced that the Aquatrack hydrophilic nitinol guidewire, a high-performance 0.035" guidewire for physicians performing complex percutaneous interventions, has received CE marking. Cordis Corporation has an exclusive worldwide agreement with Argon Medical, the product's manufacturer, to market and distribute Aquatrack.
Autogenous infrainguinal bypass outcomes inferior in Hispanics
Study shows that Hispanic patients have poorer outcomes following infrainguinal bypass grafting for the treatment of peripheral arterial disease.
TEVAR deemed safer than open repair
Study finds higher overall complication rate for open repair compared to endovascular repair of thoracic aortic aneurysm
Use the angiographic test that works for you, says Toomay
Seth Toomay says that interventions planned with computed tomography angiography or magnetic resonance angiography are equally successful
Positive results for sirolimus-eluting stents in treating CLI
Dr. Konstantinos Katsanos, presented study at the recent EuroPCR meeting in Barcelona held from May 22-25 2007.
Angioblasts may stimulate vascular regeneration
Interest generated in the use of angioblasts for neovascularization of ischemic or injured tissue
New visualization system for PAD patients
The new system combines real-time imaging with the company's FDA-cleared SilverHawk Plaque Excision system.
Cryoplasty effective in treating PAD
Results presented recently in Washington
Vascular Intervention Unit: The Workplace of the Vascular Surgeon in the 21st Century
Vascular surgeons, cardiologists and radiologists traditional work area separation to change
Profile: Christos Liapis
Vascular News talks to Christos D Liapis
New trials to evaluate stenting in peripheries
Vascular News reports of two company-sponsored trials
CMS grants New Technology Add-on Payment for Endologix’s Detour system
Endologix has announced that the US Centers for Medicare & Medicaid Services (CMS) recently granted a New Technology Add-on Payment (NTAP) for the Detour...
Promising future previewed for PAD treatment at Riga summit
This advertorial is sponsored by BD.
There has been major progress in the treatment of peripheral arterial disease (PAD) globally in the last few years,...
FDA update: Paclitaxel-coated devices for PAD cleared of excess mortality risk, proven safe and...
This advertorial is sponsored by Boston Scientific.
Data on hundreds of thousands of patients who have received lower limb endovascular treatment provide confidence in paclitaxel...
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma...
Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA)...
Endologix announces first patients treated with the Detour system
Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since US Food...
Vascular News’ top 10 most popular stories of June 2023
Highlights from this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June, National Harbor, USA) feature prominently in June's top 10.
1. “Sonolysis...
Timeline: Key milestones in the paclitaxel story
The release of a letter from the US Food and Drug Administration (FDA) concerning the use of paclitaxel-coated devices for the peripheral arterial disease...
Boston Scientific announces position on FDA update about use of paclitaxel-coated devices to treat...
Following yesterday's news that the US Food and Drug Administration (FDA) has changed its stance on the use of paclitaxel-coated devices to treat peripheral...
FDA removes red flag for paclitaxel-coated devices after review finds data do not support...
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated...
BEST-CLI investigators implore a move beyond endo versus open “battle” in the name of...
The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J Veith Distinguished Lecture at this year’s Society for...
US FDA approves Endologix’s Detour system for treating complex PAD
Endologix has announced in a press release that the US Food and Drug Administration (FDA) has granted approval for the Detour system to treat...
Connect the world session at LINC 2023 projects “outstanding” first-release data from multiple DCB...
The Connect The World Session: Japan at this year’s Leipzig Interventional Course (LINC 2023, 6–9 June, Leipzig, Germany)—in collaboration with the Japanese Endovascular...
MagicTouch sirolimus-coated balloon granted IDE approval for treatment of the SFA
On 24 May, the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) approval for Concept Medical's MagicTouch percutaneous transluminal angioplasty (PTA)...
First US patient enrolled in MedAlliance sirolimus DCB study
The first US patient has been enrolled in the SELUTION4SFA sirolimus drug-eluting balloon (DEB) study by Arthur Lee (Cardiac & Vascular Institute, Gainesville, USA)....
Real-world data consistent with RCTs in highlighting the efficacy of drug-eluting technology
This advertorial is sponsored by Boston Scientific.
During a recent satellite symposium, which took place at the 2022 Cardiovascular Interventional Radiological Society of Europe (CIRSE)...
Surmodics announces successful first patient use of Sublime radial access microcatheter designed for the...
Surmodics has announced that Ankur Lodha (Cardiovascular Institute of the South, Lafayette, USA) and Pradeep Nair (Cardiovascular Institute of the South, Houma, USA) were...
Vascular News’ top 10 most popular stories of March 2023
The US launch of a new peripheral intravascular lithotripsy (IVL) catheter, new data on large bore mechanical thrombectomy in high-risk pulmonary embolism (PE) patients,...
Results from PROMISE II pivotal trial suggest “transformational value” of deep vein arterialisation in...
Results from the PROMISE II pivotal trial investigating transcatheter arterialisation of the deep veins using the LimFlow system in so-called no-option chronic limb-threatening ischaemia...
Getinge receives US FDA premarket approval for the iCast covered stent system
Getinge's iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac...
SVS, ACS launch new quality verification programme
The Society for Vascular Surgery (SVS) and the American College of Surgeons (ACS) have launched the “Vascular Verification Program (Vascular-VP)," an ACS Quality Program...
Vascular News’ top 10 most popular stories of February 2023
February's top 10 includes the announcement that Abbott is to acquire Cardiovascular Systems, results of the PRESERVE study on the safety and effectiveness of...
Shockwave IVL: Improving compliance is the key to “best endovascular” CFA treatment
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
In this case report, Narayanan...
Shockwave IVL: Sound science reinforced by sound evidence
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Stefano Fazzini (Tor Vergata Hospital,...
Change compliance to change the game in PAD treatment: Overcome the challenge of calcium...
This educational supplement is sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
In this supplement:
Stefano Fazzini (Tor Vergata Hospital, Rome,...
Patients with claudication receive more “aggressive” surgical management in high-competition regions, study finds
Demonstrating the “susceptibility” of care delivery to regional market competition, M Libby Weaver (University of Virginia, Charlottesville, USA) presented the case that intermittent claudication...
Abbott to acquire Cardiovascular Systems
Abbott and Cardiovascular Systems (CSI) have announced a definitive agreement for Abbott to acquire CSI. Under terms of the agreement, CSI stockholders will receive...
The BeBack crossing catheter: A “game-changer” in endovascular PAD practice
This advertorial is sponsored by Bentley.
Crossing chronic total occlusion (CTO) lesions are challenging procedures. The BeBack crossing catheter—Bentley’s first product to be available in...
Cardiovascular Systems enrols first patient in Japan for KAIZEN clinical study
Cardiovascular Systems Inc (CSI) recently announced initiation of the KAIZEN clinical study of its Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment...
Vascular News’ top 10 most popular stories of November 2022
November's top 10 includes the first results from BEST-CLI, as well as new data presented at this year's Vascular Interventional Advances (VIVA; 31 October–3...
Chocolate Touch drug-coated angioplasty balloon for treatment of PAD receives FDA approval
Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA)...
CX Aortic Vienna: Presenters advocate for patient-tailored approach in thoracoabdominal procedures
Day three of CX Aortic Vienna Digital Edition (24–26 October) gave airtime to risk prediction and management for thoracoabdominal aortic aneurysm (TAAA) procedures. Presentations...
Cordis announces acquisition of MedAlliance
Cordis today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance.
A press release notes that the agreement includes an...
Endologix submits premarket approval application to FDA for Detour system
Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration...
Vascular News’ top 10 most popular stories of September 2022
September's top 10 highlights a randomised trial that aims to examine early endovascular aneurysm repair (EVAR) in women, new radiation safety guidelines from the...
Sirolimus-coated balloon a “clear alternative” to paclitaxel-coated balloons
Ulf Teichgräber (Jena, Germany) and Edward Choke (Singapore) discuss—at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK)—some of the key benefits...
SAVAL trial finds no gains with custom drug-eluting stents in PAD below the knee
Day one of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) put a strong focus on...
Bentley provides complete vascular solution with comprehensive covered stent portfolio
This advertorial is sponsored by Bentley.
The range and complexity of vascular pathologies that interventionalists face necessitates a complete and comprehensive solution. Bentley, with its coronary,...
Vascular News’ top 10 most popular stories of August 2022
The establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower extremity and arterial and venous interventions, results...
Selution SLR receives second FDA IDE approval
Selution SLR, MedAlliance's sirolimus-eluting balloon, has received conditional US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical...
First patients enrolled in LIMES randomised trial of Magic Touch sirolimus-coated balloon in BTK...
Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company's...
Cordis announces start of enrolment in RADIANCY clinical study in Europe
Cordis has announced the start of the RADIANCY premarket clinical study in Europe.
A press release details that RADIANCY is a prospective, multicentre, single-arm...
Vascular News’ top 10 most popular stories of June 2022
Coverage of this year's Leipzig Interventional Course (LINC; 6–9 June, Leipzig, Germany) and Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM; 15–18 June,...
New data on Biotronik’s Passeo-18 Lux DCB presented at LINC 2022
Biotronik recently announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC)...
Philips announces positive three-year clinical research results from its TOBA II BTK clinical trial
Royal Philips today announced the latest results from the Tack optimised balloon angioplasty (TOBA) II below-the-knee (BTK) clinical trial, demonstrating that the Philips endovascular...
Vascular News’ top 10 most popular stories of May 2022
Two-year data on the use of intravascular lithotripsy (IVL) in calcified peripheral disease treatment, an advertorial sponsored by Bentley exploring the role of bridging...
Shockwave Medical and Genesis MedTech obtain regulatory approval in China for intravascular lithotripsy
Shockwave Medical and Genesis MedTech Group announced today that they have successfully obtained approval from China’s National Medical Products Administration (NMPA) to market and...
New long-term data of paclitaxel devices continue to show no increased mortality compared to...
New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at...
Pounce thrombectomy system first-in-human data show 100% technical success in early cases
Surmodics has announced that its Pounce thrombectomy system achieved 100% technical success in 20 first-in-human (FIH) procedures. The FIH data were presented by Gary...
Vascular News’ top 10 most popular stories of March 2022
A review of intraoperative adverse events in patients treated with fenestrated and branched endovascular aneurysm repair, meta-analysis findings on peripheral arterial disease symptoms in...
Viabahn use in claudicants with long, complex SFA lesions “safe and effective” through five...
Recently published research indicates that stent grafting with the Viabahn endoprosthesis (W L Gore & Associates) of long and complex superficial femoral artery (SFA)...
Vascular News’ top 10 most popular stories of February 2022
February's top 10 includes a consensus statement from the Society for Vascular Surgery (SVS) and the Enhanced Recovery after Surgery (ERAS) Society on perioperative...
SIRONA head-to-head randomised trial achieves 50% enrolment
Concept Medical recently announced that the SIRONA randomised controlled trial (RCT)—a head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery—has...
MedAlliance acquires Japanese partner MDK Medical
MedAlliance has acquired its partner MDK Medical, a Japanese vascular specialist company. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical...
Vascular News’ top 10 most popular stories of December 2021
Highlights from the UK Vascular Societies’ Annual Scientific Meeting (VSASM 2021; 1–3 December, Manchester, UK), a VOYAGER PAD subanalysis, and Cordis' appointment of a...
Cordis names George Adams as chief medical officer
Cordis has announced George Adams as chief medical officer.
"We are delighted to have Dr Adams join our team as we continue to build the...
Vascular News’ top 10 most popular stories of November 2021
November's top 10 features a large-scale analysis of Philips' intravascular ultrasound (IVUS) in lower extremity peripheral vascular interventions, five-year data on Avenu Medical/Medtronic's Ellipsys...
Endologix announces completion of enrolment in TORUS 2 study for PAD in SFA
Endologix has completed enrolment in the TORUS 2 investigational device exemption (IDE) clinical study in the USA, a press release reports.
The TORUS 2...
Avinger announces FDA clearance of Pantheris for the treatment of in-stent restenosis
Avinger recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new clinical indication for the...
Two-year Ranger DCB data demonstrate “sustained, high rate” of device efficacy
Patients treated with the Ranger drug-coated balloon (DCB; Boston Scientific) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year...
One-year results show “superior” primary patency rate for Eluvia DES compared to bare metal...
One-year results presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA) from the EMINENT trial demonstrated the superiority of the Eluvia...
Vascular News’ top 10 most popular stories of September 2021
September's top 10 features five-year ACST-2 results, a new tool to assess amputation risk following popliteal vascular injury, and an interview highlighting the questions...
Vascular News’ top 10 most popular stories of August 2021
Research presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online)—including new VOYAGER PAD...
Medtronic receives CE mark for 200mm and 250mm IN.PACT Admiral DCBs
Medtronic has announced CE mark approval and the European launch of the 200mm and 250mm IN.PACT Admiral drug-coated balloons (DCBs). The product is intended...
Medical therapy linked with low early mortality in type B aortic intramural haematoma patients
Medical management of type B aortic intramural haematomas is associated with low early mortality but a 19% risk of aortic-related intervention—primarily for proximal descending...
FDA approves expanded PAD indication for Xarelto plus aspirin to include patients after LER...
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the US Food and Drug Administration (FDA) has approved an expanded peripheral arterial...
VOYAGER PAD: Rivaroxaban plus aspirin should be considered after lower extremity bypass regardless of...
“A strategy of adding rivaroxaban 2.5mg twice daily to aspirin should be considered after lower extremity bypass regardless of conduit type,” concluded Nicholas Govsyeyev...
Vascular News’ top 10 most popular stories of July 2021
Updated Society for Vascular Surgery (SVS) clinical practice guidelines on extracranial cerebrovascular disease management and a new meta-analysis on paclitaxel in peripheral arterial disease...
Surmodics announces successful first patient use of Pounce thrombectomy system
Surmodics has announced that J. Michael Bacharach, a vascular interventionalist/cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls, USA,...
Ali AbuRahma
“There is no doubt in my mind that working together rather than competing against each other will not only be in our best interests...
Nationwide study identifies sex disparities in long-term mortality after paclitaxel exposure
A German claims-based cohort study has revealed that—in 13,204 patients treated with a paclitaxel-coated device for peripheral arterial disease (PAD)—mortality differences were mostly attributable...
Vascular News’ top 10 most popular stories of June 2021
New data from Philips' TOBA II below-the-knee (BTK) clinical trial, physicians' call for the AMPREDICT decision support tool to be applied in clinical practice,...
Episode 3: The unique recipe for long-term clinical benefit with IN.PACT™ Admiral™ DCB
In this third episode of a special five-part series on the history of DCBs, Jos van den Berg (Lugano, Switzerland) moderates a Vascular News roundtable discussion...
Femoropopliteal bypass shows reintervention benefit over endovascular therapy for advanced premature PAD
Femoropopliteal bypass is associated with decreased reinterventions at one year compared to endovascular therapy in patients with advanced premature peripheral arterial disease (PAD). This...
Philips announces positive two-year data from TOBA II BTK clinical trial
Royal Philips recently announced positive two-year results from the TOBA (Tack optimised balloon angioplasty) II below-the-knee (BTK) clinical trial.
The data show the Philips...
Vascular News’ top 10 most popular stories of May 2021
Expanding eligibility for endovascular aneurysm repair (EVAR), new tools for chronic limb-threatening ischaemia (CLTI), and promising data for arteriovenous (AV) fistula remote monitoring all...
Concept Medical releases status updates on SIRONA RCT
Concept Medical has released a series of status updates on their head-to-head SIRONA (Sirolimus versus paclitaxel drug-eluting balloon angioplasty in femoropopliteal diseases) randomised controlled...
ACC.21: SAFE-PAD finds no increased risk of death with drug-coated devices used for lower...
Researchers have found no statistically significant difference in mortality between patients treated with drug-coated devices and non-drug-coated devices in the SAFE-PAD study. Eric Secemsky...
New tools for CLTI: ISET audience hear what’s on the horizon for these challenging...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco,...
New tools for CLTI: ISET audience hear what’s on the horizon for these challenging...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco,...
Vascular News’ top 10 most popular stories of March 2021
Newly-published data on the benefits of a dedicated vascular limb salvage clinic, key product launches in the vascular access space, and evidence to suggest...
XO Cross microcatheter platform earns CE mark approval
Transit Scientific recently received CE mark approval in the European Union for its non-tapered metal alloy XO Cross microcatheter platform, a press release reports. ...
Vascular News’ top 10 most popular stories of February 2021
New data on asymptomatic carotid disease, key developments in below-the-knee (BTK) interventions, and evidence to suggest wearable activity monitors could benefit intermittent claudication patients...