Redwood City, CA / ACCESSWIRE / December 4, 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 provided an update on the limited launch of its Tigereye™ next generation image-guided chronic total occlusion (CTO) crossing system. Avinger is conducting a limited launch at clinical centers in the U.S. and Germany during the fourth quarter of 2020 prior to a planned expansion to full U.S. commercial distribution in the first quarter of 2021.
Following clearance by the U.S. Food and Drug Administration ("FDA"), Avinger announced the completion of first U.S. cases with Tigereye in three clinical sites in October 2020. Since that time, Avinger has launched the new Tigereye catheter into five additional clinical centers in the U.S. and one hospital in Germany, where Tigereye was initially introduced under CE Marking. The first sites in the U.S and Germany continue to treat additional patients with the device. A total of 10 sites have now used Tigereye with over 40 cases successfully performed to date.
Based on the positive clinical results and excellent product reliability experienced in the limited launch program, Avinger expects to expand commercial availability of Tigereye for U.S. national launch in January 2021.
"Tigereye's performance in a variety of cases during this important limited launch phase has generated overwhelming excitement and confidence amongst users," commented Dr. Jaafer Golzar an interventional cardiologist and Avinger's Chief Medical officer. "Based on my personal initial case experiences and feedback from other physicians, the enhanced imaging, higher rotational speeds and ability to precisely control the device with variable deflection inside the vessel improve our ability to safely and effectively cross challenging CTOs.
"I have been very pleased with the efficiency of workflow and how rapidly we have been able to cross complex CTOs. We have learned a lot from these initial cases, and I believe we are just beginning to understand the true potential and harness the power of Tigereye in a variety of complex lesion subsets."
Jeff Soinski, Avinger's President and CEO, added, "Our limited launch experience reaffirms our belief that 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 completing our initial launch program and are excited about expanding to full commercial availability in January 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 national 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 and competition from other products; 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, and in our Quarterly Reports on Form 10-Q. 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.
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