Tag: FDA

No time like the present: The moral imperative for advocacy in...

“I’m so sorry but we have to cancel your surgery”—10 words any warm-blooded surgeon dreads uttering. This time around, it was not for the...

TCAR: First patient enrolled in ROADSTER 3 post-approval study

Silk Road Medical has announced enrollment of the first patient in ROADSTER 3, which the company claims is the the first prospective, multicenter, single-arm...

AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system

AngioDynamics recently announced receiving Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy. The FDA recently...

Selution SLR receives second FDA IDE approval

Selution SLR, MedAlliance’s sirolimus-eluting balloon, has received conditional Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial...

Enrollment begins in PERSEVERE clinical trial of hybrid prothesis for aortic...

Artivion announced today that it has initiated enrollment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey Type I aortic dissection...

Cordis announces start of enrollment in RADIANCY clinical study in Europe

Cordis has announced the start of the European RADIANCY premarket clinical study of a stent system designed for radial access in the treatment of...

AVeVA study confirms benefit of covered stent placement in graft-vein anastomotic...

A prospective, multicenter study involving the Covera vascular covered stent (BD) has confirmed the benefits of immediate, post-percutaneous transluminal angioplasty (PTA) placement of the...

PAD: Ra Medical Systems receives FDA 510(k) clearance for the Dabra...

Ra Medical Systems has announced receipt of Food and Drug Administration (FDA) 510(k) clearance for the company’s Dabra 2.0 catheter as part of the...

Terumo Aortic announces first commercial implant of Thoraflex Hybrid in US

Following the recent approval by the Food and Drug Administration (FDA) of the Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of...

Expanded Medicare coverage for TCAR in standard surgical risk patients...

Silk Road Medical today announced that the Centers for Medicare and Medicaid Services (CMS), through collaboration with the Society of Vascular Surgery's Patient Safety...

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 Food and Drug Administration, making it the first limus...

New long-term data of paclitaxel devices continue to show no increased...

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...

Venovo venous stent returns to US market after 2021 recall

BD recently announced that its Venovo venous stent is back on the U.S. market following a recall last year. In 2019, the company reported that the...

FDA approves expanded indications for TCAR’s Enroute stent

The Food and Drug Administration (FDA) approved expanded indications for the Enroute stent system—part of the transcarotid artery revascularization (TCAR) procedure—to include patients at...

Terumo Aortic announces FDA approval for Thoraflex Hybrid frozen elephant trunk...

Terumo Aortic today announced that the Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk device for commercial...

Shockwave Medical announces global launch of new peripheral IVL catheter

Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both Food and Drug Administration (FDA) and...

Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular...

Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the Food and Drug Administration (FDA), a press release reports.  The company...

Database analysis findings ‘matched precisely’ with reported reasons for venous stent...

A recent analysis recalled Venovo and Vici venous stents—initiated last year—characterized “significant differences” between reported device and patient issues, and subsequent interventions for the...

Ra Medical Systems receives FDA approval for increased enrollment in atherectomy...

Ra Medical Systems, a medical device company focused on developing the excimer laser system to treat vascular diseases, has announced that enrollment has reached...

FDA issues guidance documents for including patient perspectives in medical device...

The Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.   As per...

Cook Medical receives FDA breakthrough designation for new drug-eluting stent

Cook Medical has received Breakthrough Device designation from the Food and Drug Administration (FDA) on a new drug-eluting stent (DES) for below the knee...

Philips integrates cloud-based AI and 3D mapping into its mobile C-arm...

Royal Philips has announced physicians will now have access to advanced new 3D image guidance capabilities through its image-guided therapy mobile C-arm system—Zenition. The...

Our forever plague

The following is a combined and revised version of the November and December 2021 editorials on fake news and science denial published in Vascular...

FDA issues updated safety communication on use of Endologix AFX endovascular...

The Food and Drug Administration (FDA) has issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes...

FDA approves two pediatric venous thromboembolism indications for rivaroxaban

The Food and Drug Administration (FDA) has approved two pediatric indications for Xarelto (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent...

Envveno Medical reports successful completion of first VenoValve surgery in US...

Envveno Medical—formerly Hancock Jaffe Laboratories—recently announced that the first VenoValve surgery in the company’s SAVVE US pivotal trial for the VenoValve has been successfully...

Sanford invents Breakthrough Device for TAAA

An investigational device invented at Sanford Health in Sioux Falls, South Dakota, that helps high-risk vascular disease patients has been granted a Breakthrough Device...

Terumo Aortic announces first commercial implants of RelayPro in US

Terumo Aortic today announced the first commercial implants in the U.S. of its RelayPro thoracic stent-graft system. This follows the recent approval by the...

‘Tremendous advances in imaging possibilities’ signal further innovation, says leading vascular...

It was a complex repair in the thoracoabdominal region of the aorta around 10 years ago, and Matthew Eagleton, MD, and his surgical team...

FDA approves expanded PAD indication for rivaroxaban plus aspirin

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Food and Drug Administration (FDA) has approved an expanded peripheral arterial disease...

PRISTINE registry with Selution SLR sirolimus drug-eluting balloon completes enrollment

MedAlliance has announced completion of patient enrollment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee...

RelayPro thoracic stent graft approved by FDA

Terumo Aortic today (Friday, Aug. 6) announced that the Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent-graft system for...

VenoValve granted FDA Breakthrough Device designation

Hancock Jaffe Laboratories today (Wednesday, Aug. 4) announced that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to the company's...

Surmodics announces successful first patient use of Pounce thrombectomy system

Surmodics has announced that J. Michael Bacharach, MD, a vascular interventionalist/cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls,...

Surmodics builds thrombectomy portfolio with acquisition of Vetex Medical

Surmodics recently announced that it has acquired privately-held Vetex Medical Limited, expanding the company's thrombectomy portfolio with a second Food and Drug Administration (FDA) 510(k)-cleared...

Boston Scientific recalls Vici SDS and Vici RDS venous stent systems...

According to a medical device recall notice posted on the Food and Drug Administration (FDA) website, Boston Scientific has recalled its Vici venous stent...

ACC.21: SAFE-PAD finds no increased risk of death with drug-coated devices

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,...

VenoValve: Chronic venous insufficiency device gains brisk double of first US...

Hancock Jaffe Laboratories recently revealed that the United States Patent and Trademark Office (USPTO) issued the first patent covering the company’s VenoValve. The patent is...

US surgeons begin commercial use of Gore Excluder conformable AAA endoprosthesis...

W. L. Gore & Associates (Gore) today announced the first use of the Food and Drug Administration (FDA)-approved Gore Excluder conformable abdominal aortic aneurysm...

FDA grants breakthrough device designation for Zenith fenestrated+ endovascular graft

The Zenith fenestrated+ endovascular graft (ZFEN+) product (Cook Medical) has received breakthrough device designation from the Food and Drug Administration (FDA). This designation is...

Medtronic recalls unused Valiant Navion thoracic stent graft system

Medtronic has voluntarily issued a global recall of its Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the...

Postmarket study of sirolimus-eluting balloon enrolls first patient

MedAlliance has announced enrollment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment...

Treo IDE primary endpoint results announced

In the wake of approval by the Food and Drug Administration (FDA) of the Treo abdominal aortic stent-graft system for the treatment of patients...

Fluoroquinolones linked to increased incidence of aortic aneurysms in US adults

Fluoroquinolones—one of the most commonly prescribed antibiotic classes in the United States—were associated with increased incidence of aortic aneurysm formation in U.S. adults, a...

FDA representatives respond to SWEDEPAD interim analysis, highlight need for continued...

Representatives from the Food and Drug Administration (FDA) referenced "important and reassuring" results from the recent interim analysis of the SWEDEPAD clinical trial in which...

Vesper Medical announces first enrollment in the VIVID trial

Vesper Medical recently announced initiation of its Food and Drug Administration (FDA) investigational device exemption (IDE) study, VIVID (Venous stent for the iliofemoral vein investigational clinical trial...

Janssen applies to FDA for new indication to expand use of...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug...

‘Nearly nothing’ in surgery will go untouched by AI, ACS Clinical...

Almost nothing will go untouched by artificial intelligence (AI) in healthcare and surgery, notably in the quickly evolving world of vascular and endovascular surgery,...

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 been...

Terumo Aortic gains FDA approval for Treo endovascular device

Terumo Aortic has been granted Food and Drug Administration (FDA) approval for the Treo abdominal aortic stent-graft system to be sold in the U.S. The...

First US commercial use of Tack Endovascular System in BTK arteries...

Intact Vascular has announced the first commercial use of its Tack Endovascular System (4F) in multiple sites across the United States. Notably the first Food...

FDA grants Nexus aortic arch stent graft system breakthrough designation

Endospan was recently granted breakthrough device designation from the Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system. The FDA’s breakthrough...

FDA official delivers government agency’s early reaction to latest contentious meta-analysis...

HOLLYWOOD, Fla.—A Food and Drug Administration (FDA) official delivered a talk which represents the government agency’s earliest public reaction to the latest meta-analysis suggesting...

Early adaptation of SVS, STS TBAD joint document will drive robust...

The Society for Vascular Surgery (SVS) and the Society of Thoracic Surgeons (STS) recently published a joint document on reporting standards for type B...

Newly FDA-approved device for central venous occlusions hailed as exciting advance

HOUSTON—These are exciting times in the theater of dialysis access, expert in the field Eric Peden, MD, mused in the latter part of last...
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Deploying robust, detailed SVS VQI data to help better define role...

In December 2018, the Journal of the American Heart Association published “Risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal...

FDA keeps close watch on heparin dosing reports

The Food and Drug Administration (FDA) is closely monitoring reports of higher than usual doses of heparin being required to achieve activated clotting times...

SVS president presents point-by-point defense of Society position on paclitaxel controversy

NEW YORK—Kim Hodgson, MD, president of the Society for Vascular Surgery, delivered a robust defense of the SVS position on the drug-coated balloon (DCB)...

Regulatory unity can help drive medical device adoption globally, FDA official...

LAS VEGAS—Efforts at international collaboration across borders can drive harmony among disparate regulatory requirements and lead to greater global cooperation at the medical device...