Avinger (AVGR) Announces 510(k) Filing of Ocelaris Next Generation Image-guided CTO Crossing System

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 patients with Peripheral Artery Disease (PAD), today announced the Company has submitted a 510(k) application to the U.S. Food & Drug Administration (FDA) for pre-marketing clearance of Ocelaris, a next generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform.

Ocelaris is a product line extension of Avinger's Ocelot family of image-guided CTO crossing catheters. Its design elements include an upgrade of the image capture rate to provide high definition, real-time intravascular imaging similar to the company's Pantheris image-guided atherectomy system and a user-controlled deflectable tip designed to assist in steerability within the lumen. Ocelaris also features a new distal tip configuration with faster rotational speeds designed to penetrate challenging lesions. The Ocelaris catheter has a working length of 140 cm and 5 French sheath compatibility for treatment of lesions in the peripheral vessels.

Jeff Soinski, Avinger's President and CEO, commented, "This submission represents an important milestone for Avinger as we continue to expand our product portfolio of next generation image-guided devices for the treatment of PAD. With its unique combination of benefits, we believe that Ocelaris has the potential to be a significant growth driver for our CTO-crossing business and are excited to launch this innovative device into the U.S. market following pre-marketing clearance."

"Chronic total occlusions continue to present one of the most significant technical challenges to physicians treating peripheral artery disease. If we can provide the real-time information and control to help interventionalists stay within the true lumen while treating these challenging lesions, we can help them make a difference in the clinical outcomes for their patients," noted Dr. Jaafer Golzar, Avinger's Chief Medical Officer. "By combining real-time intravascular imaging with the ability for physicians to precisely control the device within the vessel, I believe that Ocelaris will prove to be a major new advance in the treatment of CTOs."

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 proprietary 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.

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