FDA Clears Expanded Indication for Reflow Medical’s Wingman Catheter

Reflow Medical Inc., a California-based medical device company, has received clearance from the U.S. Food and Drug Administration (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.
 
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 percent 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, Calif. Dr. Laird was the principal investigator for the study.
 
S. Jay Mathews, M.D., of Bradenton Cardiology Center in Bradenton, Fla., 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.”
 
The clearance follows the FDA Breakthrough Device Designation for Reflow Medical’s Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease.
 
The Breakthrough Devices Program is designed to give patients and health care providers timely access to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program offers Reflow Medical the opportunity to interact with experts at the FDA throughout the premarket review phase, in order to help speed the development, assessment and review of the device.
 
The Temporary Spur Stent System is a combination device consisting of a patented retrievable stent system having a series of radially expandable spikes designed to create multiple pathways to deliver antiproliferative drugs for increased uptake into the vessel wall and facilitate acute luminal gain, without leaving anything behind. The device was developed in response to unmet clinical needs resulting in high rates of restenosis and treatment challenges in patients with BTK disease.
 
“We are extremely grateful to the FDA for their expedited designation of the Temporary Spur Stent System as a Breakthrough Device. We plan to take full advantage of the program’s benefits, accelerating our efforts towards meeting the requirements of the review process as we advance this novel technology, with the goal of improving the lives of patients,” said Rizk.
 
As Reflow continues to build on clinical evidence supporting the Temporary Spur Stent System, the company looks forward to furthering development in other clinical areas, based on the Spur technology platform.