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 […]
Tag: Reflow
Reflow Medical Receives Approval in Japan for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease
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, […]
Reflow Medical Enrolls First Patients in the DEEPER LIMUS Study of the Temporary Spur Stent System
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 […]
Reflow Medical Announces 510(k) Clearance for an Expanded Indication for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease
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 […]
FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System
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 […]
Reflow Medical Enrolls First Patients in DEEPER OUS Spur Stent Trial
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 […]
Reflow Medical Announces Enrollment Completion in the Wing-IT IDE CTO Clinical Trial
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 […]