The Latest Cardiac and Vascular News
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc. announced the six-month results of the DEEPER OUS clinical trial (NCT03807531) evaluating the safety and efficacy of the Bare Temporary Spur Stent System. Results were presented at the annual Leipzig International Course (LINC) in Leipzig, Germany. Michael Lichtenberg, MD, FESC, Chief Medical Officer and Director of the Angiology and […]
SAN CLEMENTE, CA /October 7, 2020 /Business Wire/ — Reflow Medical, Inc., a California- based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a California-based medical device company, has enrolled the first patients in A Non-RanDomized Pilot Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base Drug-coated Balloon (DEEPER LIMUS). The OUS single center clinical trial (NCT04162418) is expected to enroll […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a California-based medical device company, has announced that they have received clearance from the FDA for an expanded indication for the Wingman™ Crossing Catheter after completing the Wing-IT clinical trial. The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip that creates a channel to help penetrate, or […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). The Breakthrough Devices Program is designed to give patients and health care […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc. announces that the first patients have been enrolled in its DEEPER OUS clinical trial using the Temporary Spur Stent System. DEEPER OUS is a 100-patient prospective, non-randomized, multicenter trial designed to assess the safety and efficacy of the Temporary Spur Stent System compared to a meta-analysis of published data […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc. has announced the completion of enrollment in its Wing-ITinvestigational device exemption trial, a prospective, multicenter, nonrandomized study evaluating the ability of the Wingman catheter to cross chronic total occlusions (CTOs) in peripheral lesions after failed guidewire attempts. Eighty-five patients with advanced peripheral artery disease enrolled in the Wing-IT trial were evaluated […]
