Reflow Medical has announced that they have received US Food and Drug Administration (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 bevelled 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, multicentre 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 (Adventist Heart and Vascular Institute, St Helena, USA). Laird was the principal investigator for the study.
S Jay Mathews (Bradenton Cardiology Center, Bradenton, USA), who performed initial patient enrolments, said, “Reflow goes the extra mile to provide physicians with real clinical evidence for utilising 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.”