Avinger Announces First US Cases with TIGEREYE(TM) Image-Guided CTO Crossing Catheter
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™ 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.
About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our future performance, the potential benefits of TIGEREYE, the potential of TIGEREYE to be a significant growth driver for our CTO-crossing business, the benefits of TIGEREYE in the treatment of CTOs, and the anticipated launch timing of TIGEREYE into the U.S. market. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include the resource requirements related to TIGEREYE; the outcome of clinical trial results; competition from other products, and requirements to obtain regulatory approval to commercialize TIGEREYE; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2020. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements, except as required by law.