Benzinga | Oct 19, 2020 07:12AM EDT

Avinger Announces First US Cases With TIGEREYE Image-Guided CTO Crossing Catheter; Says Physicians At Three US Sites Have Treated Patients Using TIGEREYE

REDWOOD CITY, CA / ACCESSWIRE / October 19, 2020 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in three U.S. sites have successfully treated patients with the TIGEREYE(tm) next generation image-guided chronic total occlusion (CTO) crossing system. These cases are part of a limited launch at up to 10 top clinical centers prior to expanding commercial distribution to additional treatment facilities in the U.S.

The first TIGEREYE cases in the U.S. were performed by Dr. Jaafer Golzar, an interventional cardiologist and Avinger's Chief Medical Officer, Dr. Ian Cawich, an interventional cardiologist at Arkansas Heart Hospital, and Dr. Glen Schwartzberg, a vascular surgeon at Baton Rouge General Hospital. All three physicians are highly experienced interventionalists who treat numerous patients with CTOs annually, often involving complex interventions.

Commenting on his first cases, Dr. Cawich said, "While CTOs often present the most difficult and challenging cases we treat, TIGEREYE provides a significant leap forward in image quality, rotational speed and steerability critical to safely and effectively navigate difficult to cross CTOs. I was very pleased with the performance of the device and the successful outcomes I was able to achieve for my patients."

Dr. Schwartzberg noted, "Based on my initial experience with TIGEREYE, I believe this device represents a major advancement over other treatment options for CTOs that will enable a higher standard of care for patients suffering from this severe form of PAD. The enhanced imaging and precise control provided by TIGEREYE should help interventionalists tackle the toughest occlusions, while preserving the integrity of the vasculature."

"We are excited with the positive outcomes that interventionalists can achieve using Avinger's proprietary image-guided catheters for PAD therapy," commented Jeff Soinski, Avinger's President and CEO. "Just as Pantheris SV opened access to another high demand segment of the PAD market, we believe TIGEREYE represents an important growth opportunity in addressing the CTO segment with unparalleled imaging and control for physicians seeking better solutions on behalf of their patients. We look forward to continuing our initial U.S. launch program and anticipate expanding to full commercial availability in the first quarter of 2021."

TIGEREYE is a product line extension of Avinger's Ocelot family of image-guided CTO crossing catheters. Its design elements include high definition, real-time intravascular imaging and a user-controlled deflectable tip designed to assist in steerability within the lumen. TIGEREYE also features a new distal tip configuration with faster rotational speeds up to 1000 RPM designed to penetrate challenging lesions. The TIGEREYE catheter has a working length of 140 cm and 5 French sheath compatibility for treatment of lesions in the peripheral vessels both above and below the knee. TIGEREYE is complementary to Avinger's best-in-class image-guided atherectomy line up, including the Pantheris Next Generation and Pantheris SV devices.

Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.