US-based medical device company Reflow Medical has secured approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its Wingman Cross Chronic Total Occlusions (CTO) Catheter.
The company partnered with Tokyo-based medical device distributor Century Medical (CMI) for the launch of the Wingman CTO Catheter in Japan.
Using an extendable bevelled tip, the Wingman Catheter crosses peripheral CTOs in peripheral artery disease.
Wingman Catheter provides physicians with controls the advancement and activation of the tip to form a channel to help penetrate, or cross, the occlusion with a guidewire, allowing additional treatment of the lesion with therapeutic devices.
PMDA approval derives from Wing-IT CTO clinical trial that treated 85 patients and followed them for a period of 30 days.
Wing-IT CTO clinical trial is a prospective, international, multicenter study reported 90% crossing rate for Reflow’s catheter when up to two previous guidewires could not cross the CTO’s.
CMI president and CEO Takahiko Motani said: “We are very excited to launch the Wingman CTO catheter in the Japanese market. 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.”
Reflow Medical co-founder and CEO Isa Rizk added: “It is an honour for our device to have gained approval by Japan’s PMDA. We are grateful for the opportunity to partner with a fantastic organisation like Century Medical.”
In March, the US Food and Drug Administration (FDA) cleared the catheter for the expanded CTO indication, following the completion of the Wing-IT clinical trial.
Earlier, in January, the company obtained breakthrough device designation for its Temporary Spur Stent System from the FDA.