Reflow Medical has announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman chronic total occlusion (CTO) catheter. Reflow Medical has partnered with Century Medical, a medical device distributor based in Tokyo, to introduce the Wingman CTO catheter in Japan.
The Wingman catheter crosses peripheral CTOs using an extendable bevelled tip. The physician controls the advancement and activation of the tip to create a channel to help penetrate, or cross, the occlusion with a guidewire, enabling further treatment of the lesion with therapeutic devices. The catheter is compatible with the physician’s preferred guidewire and procedural technique.
Approval by Japan’s PMDA follows the completion of the Wing-IT CTO clinical trial, 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 the CTOs, meeting its primary safety and efficacy endpoints.
“Reflow Medical focuses their efforts on developing technologies based on physicians’ needs,” said John R Laird (Adventist Heart and Vascular Institute, St Helena, USA). Laird was the principal investigator for the study. “We rely on Reflow for real clinical evidence when utilising the technology.”
Reflow’s Wingman crossing catheter received clearance from the US Food and Drug Administration for the expanded CTO indication for the Wingman crossing catheter in March 2020 after completing the Wing-IT clinical trial.