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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…
ATEV shows promise in high-risk patients on hemodialysis
Results from the CLN-PRO-V007 pivotal phase 3 clinical trial of the acellular tissue engineered vessel (ATEV; Humacyte) in arteriovenous access for patients at high risk of autologous arteriovenous fistula (AVF) maturation failure with end-stage renal disease were presented at the…
Award-winning basic science research targets ‘highly complex’ process of vascular calcification
“We were really excited to know that the SVS [Society for Vascular Surgery] is supporting our research,” Sujin Lee, MD, told Vascular Specialist on receiving the SVS Foundation James S.T. Yao Resident Research Award for a paper examining the role of…
‘Rise together’: Harris urges unity in Women’s Vascular Summit presidential address
Society for Vascular Surgery (SVS) Vice President Linda Harris, MD, extolled the values of “co-elevation” in her presidential address at the 7th annual Women’s Vascular Summit (May 2–3), invoking lessons on teamwork from the world of sport to argue that…
CGuard Prime carotid stent gains US and European approvals for stroke prevention
InspireMD has been granted premarket approval (PMA) from the Food and Drug Administration (FDA) for its CGuard Prime carotid stent system in the U.S.—news that follows the company’s recent announcement of CE-mark approval under the European Medical Device Regulation (MDR).…
Gore Tag thoracic branch endoprosthesis receives expanded FDA approval for endovascular aortic arch repair
Gore has announced that the Gore Tag thoracic branch endoprosthesis (TBE) is now approved by the Food and Drug Administration (FDA) for use in Zones 0 and 1, expanding its indication for the endovascular repair of lesions in the aortic…
Increased experience with off-the-shelf TAAA endograft sees reduction in complications but no effect on mortality
Michele Piazza, MD, informed attendees of the 2025 Vascular Annual Meeting (VAM) that increased experience with the E-nside (Artivion) off-the-shelf preloaded inner branch endograft for branched endovascular aneurysm repair (BEVAR) leads to a “significant” reduction in intraprocedural complications, but does not…
Penumbra’s STORM-PE randomized trial completes enrollment
Penumbra has announced the completion of enrollment in the STORM-PE clinical trial. The pivotal, prospective, multicenter randomized controlled trial enrolled 100 patients to evaluate computer assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash plus anticoagulation versus anticoagulation alone for the treatment…
Aventus thrombectomy system gains FDA clearance for PE treatment
Inquis Medical has announced that its Aventus thrombectomy system has received 510(k) clearance from the US Food and Drug Administration (FDA) for an expanded indication to treat pulmonary embolism (PE). The Aventus System is a next-generation mechanical thrombectomy platform developed…
New THRIVE data on CAVT technology for acute limb ischemia show ‘fewer complications, hospital resource use’
Recent THRIVE study data show that Penumbra’s computer-assisted vacuum thrombectomy (CAVT) technology not only has the potential to improve outcomes for lower extremity acute limb ischemia (LE-ALI) patients, but may also reduce healthcare resource use, thus potentially lowering overall costs…