ReFlow Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Wingman14C crossing catheter for use in conjunction with a guidewire to access discrete regions of the coronary vasculature.
The FDA ruling clears the way for the Wingman14C crossing catheter to be used for the coronary arteries. ReFlow previously received 510(k) clearance to market Wingman devices for use in the peripheral vasculature.
The crossing catheter, similar to the devices for the peripheral system in concept, is specifically designed and adapted for use in coronary vasculature and complex below-the-knee lesions.
“This is a very important milestone for ReFlow Medical,” says chief executive officer, Isa Rizk. “It begins our quest to build a strong coronary chronic total occlusion 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.”