Reflow Medical, Inc., a California-based medical device company, 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005741/en/
Wingman CTO Catheter (Photo: Business Wire)
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