Articles from Reflow Medical, Inc.

Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon.

Reflow Medical, Inc., a leading developer of innovative devices for treating complex cardiovascular disease, announces the presentation of the first six-month clinical results from the DEEPER CORONARY study at EuroPCR 2026 in Paris, France. The study evaluates the investigational coronary Spur® Elute Sirolimus-Eluting Retrievable Stent System for coronary in-stent restenosis (ISR).

Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, today announced the U.S. market launch of its next-generation Cora Flex® and Cora Force® Torqueable Microcatheters, now commercially available.

Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announces that 12-month results from the DEEPER REVEAL clinical trial (NCT05358353) were presented for the first time today at the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting in Toronto, Canada.

Reflow Medical, Inc., a leading developer of innovative devices for treating complex cardiovascular disease, announces the completion of enrollment in the DEEPER CORONARY study. This pilot study evaluates the Spur® Elute Coronary Sirolimus-Eluting Retrievable Scaffold System as a primary treatment for in-stent restenosis (ISR) of the coronary arteries (NCT06117150).

Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company’s Spur Peripheral Retrievable Stent System, a unique clinical solution for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease.

Reflow Medical, Inc., a leading developer of innovative medical devices for complex cardiovascular disease, has announced the opening of its European subsidiary in Landsberg am Lech, Germany. This strategic expansion strengthens the company’s international presence and enhances its ability to serve markets outside the United States.

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 often associated with an increased risk of death and rehospitalization. Known as the Coronary Sirolimus-Eluting Retrievable Scaffold System, or “Spur Elute,” this unique clinical solution is intended to treat patients with coronary ISR by transferring a proprietary sirolimus drug formulation to the diseased lesion without leaving a permanent metallic implant behind. The study is approved to enroll a total of 10 patients at up to three centers in New Zealand.

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 provide stent-like results while leaving no metal behind. The study enrolled 130 patients in over 35 clinical centers in the U.S.

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 a commercially available drug-coated balloon (DCB) to enhance drug absorption.

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.

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.

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 status by the U.S. Food & Drug Administration (FDA) in August 2021.

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 may reduce acute vessel recoil and dissections.

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.