Reflow Medical said today that it won 510(k) clearance from the FDA for a new indication for its Wingman14C crossing catheter in treating blocked coronary arteries.
The Wingman device is already cleared in the U.S. and Europe for treating blocked peripheral vessels, the San Clemente, Calif.-based company said. The device is designed for treating both coronary and below-the-knee vessels, Reflow said.
“This is a very important milestone for Reflow Medical,” CEO Isa Rizk said in prepared remarks. “It begins our quest to build a strong coronary CTO portfolio to complement our already strong peripheral portfolio. We will continue to work closely with physicians as we develop new products to help treat cardiovascular disease.”
In April Reflow recalled some 2,327 of its Wingman35 catheters, after receiving two complaints that the device’s tip split or separated.