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Reflow Medical Announces 510(k) Clearance for an Expanded Indication for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease

March 5, 2020 GMT
The Wingman Catheter demonstrated a 90% crossing rate when up to two previous guidewires could not cross these challenging lesions, meeting its primary safety and efficacy endpoints. (Graphic: Business Wire)
The Wingman Catheter demonstrated a 90% crossing rate when up to two previous guidewires could not cross these challenging lesions, meeting its primary safety and efficacy endpoints. (Graphic: Business Wire)

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Mar 5, 2020--

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 cross, the occlusion with a guidewire, enabling further treatment of the lesion with therapeutic devices.

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The Wingman Catheter demonstrated a 90% crossing rate when up to two previous guidewires could not cross these challenging lesions, meeting its primary safety and efficacy endpoints. (Graphic: Business Wire)

The Wing-IT CTO clinical trial was a prospective, international, multicenter study that treated 85 patients and followed them for 30 days. The Wingman Catheter was able to demonstrate a 90% crossing rate when up to two previous guidewires could not cross these challenging lesions, meeting its primary safety and efficacy endpoints. These clinical trial results have garnered positive feedback in the physician community.

“With this expanded indication, physicians gain the ability to cross (CTOs) in peripheral lesions with a simple and very effective device,” according to John R. Laird, MD, of Adventist Heart and Vascular Institute in St. Helena, California. Dr. Laird was the principal investigator for the study.

S. Jay Mathews, MD, of Bradenton Cardiology Center in Bradenton, Florida, who performed initial patient enrollments, said, “Reflow goes the extra mile to provide physicians with real clinical evidence for utilizing their technology, including this new indication for the Wingman.”

Company Co-founder and CEO Isa Rizk noted, “We are extremely grateful to the physician investigators, patients, research staff and employees who helped us conduct this very important and compelling clinical study that supported this expanded treatment option for crossing peripheral CTOs.”

About Reflow Medical, Inc.

Reflow Medical, Inc. is a private company focused on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease. Reflow is developing a family of products to treat cardiovascular disease.

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CONTACT: Jennifer Carlyle

jcarlyle@reflowmedical.com

949-481-0399

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: FDA MEDICAL DEVICES HEALTH CLINICAL TRIALS CARDIOLOGY

SOURCE: Reflow Medical, Inc.

Copyright Business Wire 2020.

PUB: 03/05/2020 11:47 AM/DISC: 03/05/2020 11:47 AM

http://www.businesswire.com/news/home/20200305005662/en