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PROMISE III: Six-month data ‘reinforce’ case for TADV in no-option CLTI patients
Six-month outcomes among no-option chronic limb-threatening ischemia (CLTI) patients treated using transcatheter arterialization of the deep veins with the LimFlow system (Stryker/Inari Medical) in the PROMISE III trial showed a 81% rate of amputation-free survival. Principal investigator Daniel Clair, MD,…
The globalization of aortic innovation: A cautionary tale of U.S. regulatory overreach
In 1954, Dr. Michael DeBakey transformed vascular surgery with a homemade Dacron graft sewn on his wife’s sewing machine. His spirit of innovation laid the foundation for decades of U.S.-led advancement in aortic technology. However, recent trends suggest that this…
Appeal filed over ‘not-approvable’ letter for breakthrough venous valve replacement
Venous valve developer enVVeno Medical has announced that it will file a request for supervisory appeal of the “not-approvable” letter from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) received on Aug. 19,…
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…
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…
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…
Vivasure Medical submits premarket approval to FDA for PerQseal Elite closure system
Vivasure Medical has announced the submission of a premarket approval application to the Food and Drug Administration (FDA) for its PerQseal Elite vascular closure system for arterial procedures. In a recent press release the company has stated that the submission…
Senior vascular surgeons: 10 options beyond the operating room
As vascular surgeons advance in their careers, many begin to consider alternative professional paths that draw upon their clinical expertise, while offering greater flexibility, intellectual stimulation or new challenges outside the traditional confines of full-time clinical practice. Whether motivated by…
Gore announces FDA approval and first commercial implant of large-diameter thoracic tapers
Gore recently announced the expansion of the Gore Tag conformable thoracic stent graft with Active Control system product line, following Food and Drug Administration (FDA) approval of four new large-diameter tapered designs: 34x28mm, 37x31mm, 40x34mm and 45x37mm. News of the…