Avinger Receives CE Marking for Ocelaris, a 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 systems for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced it has gained Conformité Européenne (CE) Marking for Ocelaris, a next-generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform. CE Marking allows clinical use of Ocelaris in the European Union (EU) and certain other countries that recognize CE Marking. Ocelaris is not available for clinical use in the United States at this time.
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 imaging similar to the company's Pantheris image-guided atherectomy system, a user-controlled deflectable tip designed to assist in steerability within the lumen, and a new distal tip configuration with faster rotational speeds designed to penetrate challenging lesions. Ocelaris has a working length of 140 cm and 5 French sheath compatibility to reach distal regions of the vasculature.
Avinger plans to support first cases with Ocelaris at limited clinical sites in Germany prior to expanding distribution within Europe. Avinger anticipates filing a 510(k) submission to the United States Food and Drug Administration (FDA) in 2020 to seek pre-marketing clearance for commercial distribution in the United States.
Jeff Soinski, Avinger's President and CEO, commented, "We believe Ocelaris will help propel the clinical applicability of our image-guided CTO-crossing franchise as a single-platform for peripheral vessels above and below the knee. We are excited about the achievement of this important milestone for our company and look forward to our first case experience with this innovative new device in the coming weeks."
"Chronic total occlusions continue to present one of the most significant technical challenges to interventionalists treating peripheral artery disease and are associated with poorer procedural success rates, higher complication rates, and typically require repeat interventions," noted Dr. Jaafer Golzar, Avinger's Chief Medical Officer. "Avinger's Ocelot image-guided system represented a great step forward enabling operators to stay within the true lumen while crossing CTOs, which is desirable to reduce vascular injury and allow for a broader range of treatment options. I believe Ocelaris will further advance the platform and our mission of improving the standard of care for patients with peripheral artery disease."
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-ever image-guided, catheter-based system that diagnoses and treats 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 Avinger's the benefits of Ocelaris, reduction in radiation exposure, and increased clinical applicability of Ocelaris technology. 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 our dependency on a limited number of products; our ability to demonstrate the benefits of our Lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results; potential exposure to third-party product liability, intellectual property and other litigation; lack of long-term data demonstrating the safety and efficacy of our Lumivascular platform products; experiences of high-volume users of our products may lead to better patient outcomes than those of physicians that are less proficient; reliance on third-party vendors; dependency on physician adoption; reliance on key personnel; and requirements to obtain regulatory approval to commercialize our 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, 2019. 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.