Tag: ReFlow Medical

Reflow Medical Enrolls First Patients in Pilot Study of Coronary Sirolimus-Eluting Retrievable Scaffold System (Spur Elute)

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a developer of innovative devices focused on cardiovascular disease, announces the first patient enrollments in “A pilot study of the Drug-Eluting Coronary Spur™ StEnt as a Primary trEatment for in-stent Restenosis (ISR) of the CORONARY arteries” (DEEPER CORONARY, NCT06117150). ISR is a common clinical problem that can generate significant health care costs and is […]

Reflow Medical Completes Enrollment in the DEEPER REVEAL Clinical Trial

May 09, 2024 07:00 AM Eastern Daylight Time SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a developer of innovative devices focused on cardiovascular disease, announces completion of enrollment in the DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Spur™ Stent. Designated a Breakthrough Device by the FDA, the Spur is a unique clinical solution intended to […]

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions

San Clemente, CA—Jan. 15, 2024 – Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System. The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with […]

Reflow Medical Introduces the coraCatheters™ Line and Expands into Complex Percutaneous Coronary Interventions (PCI)

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc. announced that it has received FDA commercial clearance for its coraCatheters™, a complete line of state-of-the-art microcatheters engineered to access and cross complex and challenging lesions in percutaneous coronary interventions. The coraCatheters family of novel devices is the latest in the Reflow portfolio, which includes the Wingman™ and Spex™ […]

First Patient Enrolled in Reflow Medical’s DEEPER REVEAL IDE Clinical Study

San Clemente, CA—Reflow Medical, Inc., a medical device company focused on cardiovascular disease announces that the first patient was successfully treated and enrolled in the DEEPER REVEAL investigational device exemption (IDE) clinical trial (NCT05358353) at Advanced Cardiac & Vascular Centers (ACV) in Grand Rapids, Michigan. The Bare Temporary Spur Stent System was granted Breakthrough Designation […]

Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a California-based medical device company, has completed enrollment in the DEEPER LIMUS clinical trial (NCT04162418) to evaluate the Temporary Spur Stent System, a patented device designed to treat long, diffuse and severely calcified infrapopliteal disease. The system allows for uniform expansion of the stent to maximize lumen diameter and […]

Enrollment Completed in Reflow Medical’s DEEPER OUS Clinical Trial

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the company’s Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease. 106 patients have now been enrolled in the prospective, nonrandomized trial in multiple centers in […]

Reflow Medical Introduces the Spex™ LP, the Lowest Profile Shapeable Reinforced Support Catheter

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a California-based medical device company, introduces the Reflow™ Spex™ LP (Low Profile) 0.014 and 0.018-inch reinforced support catheters. The new Spex LP is engineered to provide the lowest profile tip for accessing and crossing the tightest and most complex lesions with a supportive system. It also features three radiopaque markers that […]

Reflow Medical Enrolls First Patients in DEEPER OUS Spur Stent Trial

San Clemente, Calif., July 30th, 2019–(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 […]

Reflow Medical announces enrollment of its first patients in the Wing-IT IDE clinical trial

San Clemente, Calif., March 12, 2018 /PRNewswire/ — Reflow Medical Inc., a developer of innovative medical devices to combat cardiovascular disease, announced that the first patients have been enrolled in a prospective, multi-center, non-randomized study intended to evaluate the ability of the Reflow Wingman Catheters to cross chronic total occlusions (CTOs) in peripheral lesions. Initial […]