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FDA begins ‘real-time’ reporting of adverse event data
The Food and Drug Administration (FDA) recently announced that it has begun daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS). The agency says that “this represents a significant step forward in modernizing the agency’s…
SWEDEPAD re-opens paclitaxel safety discussion, finds drug-coated devices do not improve outcomes
Drug-coated balloons and stents were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in the SWEDEPAD 1 and 2 trials. In addition, higher five-year mortality with drug-coated devices in patients with intermittent…
Final patient treated in Cook’s Zenith Fenestrated+ endovascular graft clinical study
Cook Medical has enrolled the final patient in the global clinical study of its Zenith Fenestrated+ endovascular graft (ZFEN+), signifying completion of patient recruitment in the pivotal study. The investigational ZFEN+ clinical study is being conducted under an Investigational Device Exemption…
Journal of Vascular Surgery secures new editor-in-chief
The Journal of Surgery (JVS) has appointed Audra Duncan, MD, of Western University in London, Ontario, Canada, as its new editor-in-chief. Duncan will lead the journal for a four-year term, renewable for two more years, following the decision of the…
Boston Scientific recalls Carotid Wallstent Monorail devices over ‘manufacturing defect’
Boston Scientific has recalled its Carotid Wallstent Monorail endoprosthesis owing to a “manufacturing defect” that has led to devices having an inner lumen that is smaller than specifications, causing resistance when withdrawing the stent delivery system. A Food and Drug…
Pharmacologic treatment, follow-up in cessation services help drive abstinence in PAD patients
A recent French study suggests smoking cessation in patients with peripheral arterial disease (PAD) is achievable with intensive and appropriate management, with the prescription of a pharmacologic smoking cessation treatment and follow-up with smoking cessation services both identified as important…
AI: Where it lands today and how it might impact the vascular future
The speed with which artificial intelligence (AI) is beginning to envelope aspects of the human experience strikes many as jarring. Its entrance into the world of vascular surgery, too, has picked up a pace in recent years, with models and…
Abbott’s Esprit BTK system receives CE mark
Abbott today announced it has received CE mark approval in Europe for the Esprit BTK everolimus-eluting resorbable scaffold system (Esprit BTK system), a technology designed for the treatment of below-the-knee (BTK) peripheral arterial disease (PAD). Abbott notes that the Esprit…
FDA grants approval for IDE study on Advance Evero 18 everolimus-coated balloon catheter
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Advance Evero 18 everolimus-coated percutaneous transluminal angioplasty (PTA) balloon catheter, the company reported today. The clinical study…
FDA deems Envveno’s VenoValve ‘not-approvable’
The Food and Drug Administration (FDA) has issued a letter to Envveno Medical stating that its VenoValve technology is “not-approvable,” a company press release published today reports. The letter was issued in response to Envveno’s premarket approval (PMA) application for…