Avinger Announces 510(k) Filing of Ocelaris Next Generation Image-guided CTO Crossing System
REDWOOD CITY, CA / ACCESSWIRE / May 20, 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 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.
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.
Forward-Looking Statements
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 Ocelaris, the potential of Ocelaris to be a significant growth driver for our CTO-crossing business, the benefits of Ocelaris in the treatment of CTOs, and the potential launch of Ocelaris into the U.S. market following pre-market clearance. . 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 Ocelaris ; the outcome of clinical trial results; ; competition from other products, and requirements to obtain regulatory approval to commercialize Ocelaris; 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.
Investor Contact:
Mark Weinswig
Chief Financial Officer
Avinger, Inc.
(650) 241-7916
ir@avinger.com
Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com
SOURCE: Avinger, Inc.
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