September 11, 2020

FDA Clears Avinger’s Next-Gen Ocelaris CTO Crossing System, to Be Marketed as Tigereye

September 11, 2020—Avinger, Inc. announced that the company received FDA 510(k) clearance for its Ocelaris next-generation image-guided chronic total occlusion (CTO) crossing system for the treatment of patients with peripheral artery disease. The device will be marketed under the brand name Tigereye.

According to the company, the device provides real-time imaging from inside the vessel during a CTO crossing procedure. The Tigereye product line is an extension of Avinger’s Ocelot family of image-guided CTO crossing catheters.

The Tigereye includes an upgrade of the image capture rate to provide high-definition, real-time intravascular imaging (similar to the Avinger Pantheris image-guided atherectomy system) and a user-controlled deflectable tip designed to assist in steerability within the lumen. Tigereye also features a new distal tip configuration with rotational speeds up to 1,000 RPM to penetrate challenging lesions. The Tigereye catheter has a working length of 140 cm and 5-F–sheath compatibility for treatment of lesions in the peripheral vessels both above and below the knee, stated Avinger.


September 14, 2020

Prediction Model Developed for Patient Outcomes With Cook Medical’s Zilver PTX DES

September 10, 2020

Study Compares Avenu Ellipsys Access System and BD WavelinQ for pAVF Creation