Regulatory

SUPIRA MEDICAL INITIATES U.S. EARLY FEASIBILITY STUDY (EFS) FOR HIGH-RISK PCI

Company expands clinical program beyond 70 patients already treated in South America FIH and Feasibility Studies. FDA acknowledged potential benefits of the Supira System by granting the company a review pathway under the Breakthrough Device Program. Results from EFS will be used to support submission to FDA for Supira’s pivotal […]

FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD. 

Medtronic receives CE Mark for Evolut™ FX+ TAVI system for treatment of symptomatic severe aortic stenosis

Medtronic plc, a global leader in healthcare technology, today announced it has received CE (Conformité Européenne) Mark for the Evolut™ FX+ transcatheter aortic valve implantation (TAVI) system, the company’s latest Evolut TAVI system for the treatment of symptomatic severe aortic stenosis. This follows the recent United States Food and Drug […]

Pi-Cardia Receives FDA Market Clearance for ShortCut™

REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of leaflet modification solutions for treating heart valves, announced today that the United States Food and Drug Administration (FDA) provided market clearance for ShortCut™ – the world’s first dedicated leaflet modification device, enabling valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures […]