Avinger Gains FDA Clearance for Image-Guided Catheter

Avinger’s Ocelaris Tigereye image-guided chronic total occlusion- (CTO) crossing catheter system has obtained 510(k) clearance from the FDA.

The device provides real-time imaging from inside the blood vessel during CTO-crossing procedures. It features an upgraded image-capture rate for high-definition imaging and a user-controlled deflectable tip to assist in steering the device.

The catheter also features faster rotational speeds to improve the penetration of lesions. The company said it will begin a limited launch of the product in the fourth quarter and expects a full national launch early next year.