October 8, 2020
Reflow Medical, Inc. has announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter.
Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO Catheter in Japan.
The Wingman Catheter crosses peripheral CTOs using an extendable beveled 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, 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 the CTOs, meeting its primary safety and efficacy endpoints.
“We are very excited to launch the Wingman CTO catheter in the Japanese market,” said CMI President and CEO Takahiko Motani. “This product should have a significant impact on the Japanese peripheral market by helping physicians address specific treatment challenges within a growing patient population. We look forward to providing this new and unique device in partnership with Reflow Medical, Inc.”
“Reflow Medical focuses their efforts on developing technologies based on physicians’ needs,” said John R. Laird, MD, of Adventist Heart and Vascular Institute in St. Helena, California. Dr. Laird was the principal investigator for the study. “We rely on Reflow for real clinical evidence when utilizing the technology.”
“It is an honor for our device to have gained approval by Japan’s PMDA,” noted Reflow Medical Co-founder and CEO Isa Rizk. “We are grateful for the opportunity to partner with a fantastic organization like Century Medical.”
Reflow’s Wingman Crossing Catheter received clearance from the U.S. Food and Drug Administration for the expanded CTO indication for the Wingman Crossing Catheter in March 2020 after completing the Wing-IT clinical trial.