Benzinga | Apr 8, 2021 08:36AM EDT

Avinger Says Tigereye Has Now Been Launched In 30 Clinical Sites

vinger, 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 provided an update on the commercial launch of Tigereye CTO Crossing catheters for the treatment of PAD.

Following limited launch in the fourth quarter of 2020, Avinger initiated full commercial launch of Tigereye in January 2021. Tigereye has now been launched in 30 clinical sites with more than 160 cases successfully performed. Avinger territory sales managers have opened an average of 2.7 sites per person since launch. Tigereye revenue is expected to drive an approximately 60% increase in Avinger's combined Lumivascular CTO revenue for the first quarter of 2021 compared to the year-ago period.

Jeff Soinski, Avinger's President and CEO, commented, "The commercial launch of our Tigereye device is delivering consistent and compelling patient outcomes to a growing number of Avinger sites, now totaling 30 treatment facilities. Physicians are consistently, safely and effectively crossing complex CTOs using Avinger's Tigereye catheter, distinguishing our solution in the market. We believe the patient outcomes and commercial uptake of the Tigereye device demonstrate the clinical demand for this technology."

"Without an advanced technology like Tigereye, many patients with CTOs may require a high rate of repeat intervention or a surgical bypass or amputation," commented Dr. Ian Cawich, an interventional cardiologist at Arkansas Heart Hospital and a leading user of Tigereye. "In the case of a bypass or amputation, these far more invasive procedures can have serious risks and long-lasting consequences to patient quality of life. Tigereye's onboard image-guidance combined with a powerful CTO crossing mechanism offers an innovative approach for successfully traversing these challenging lesions and facilitates a minimally invasive and durable outcome for these patients."

The Tigereye CTO crossing system features high definition, real-time intravascular imaging and a user-controlled deflectable tip designed for steerability within the lumen. Tigereye also includes an enhanced distal tip configuration with 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 to enable treatment of lesions in peripheral vessels both above and below the knee. Tigereye is complementary to Avinger's image-guided atherectomy line of catheters, including the Pantheris Next Generation and Pantheris SV catheters.

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 and 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, due to real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.