March 3, 2020
FDA Clears Expanded Indication for Reflow Medical’s Wingman Catheter to Cross Peripheral CTOs
March 3, 2020—Reflow Medical, Inc. announced FDA clearance for an expanded indication for the Wingman crossing catheter after completing the Wing-IT clinical trial. The Wingman catheter crosses peripheral chronic total occlusions (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.
According to the company, the Wing-IT CTO clinical trial, which commenced in March 2018, was a prospective, international, multicenter study that treated 85 patients who were followed for 30 days. 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.
“With this expanded indication, physicians gain the ability to cross CTOs in peripheral lesions with a simple and very effective device,” commented John R. Laird, MD, Principal Investigator of the Wing-IT trial, in the company’s announcement. Dr. Laird is from Adventist Heart and Vascular Institute in St. Helena, California.
S. Jay Mathews, MD, who performed initial patient enrollments in the study, added, “Reflow goes the extra mile to provide physicians with real clinical evidence for utilizing their technology, including this new indication for the Wingman.” Dr. Mathews is from Bradenton Cardiology Center in Bradenton, Florida.