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REDWOOD CITY, CA / ACCESSWIRE / January 9, 2020 / Avinger, Inc. (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 the first clinical experiences with the Ocelaris next-generation CTO crossing system utilizing Avinger's proprietary image-guided technology platform.
Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital Münster, and Dr. Michael Lichtenberg, an interventional angiologist at Klinikum Hochsauerland, Arnsberg, used Ocelaris in multiple procedures across a variety of different lesion types and anatomy both above and below the knee. Avinger plans to continue supporting first cases with Ocelaris at limited clinical sites in Germany prior to expanding distribution within Europe. Avinger received CE Marking for Ocelaris in December 2019. The company anticipates filing a 510(k) submission to the United States Food and Drug Administration (FDA) in the first half of 2020 to seek pre-marketing clearance for commercial distribution in the United States. Ocelaris is not available for clinical or commercial use in the United States at this time.
Commenting on his initial experience with Ocelaris, Dr. Schwindt noted, "The high definition, real-time imaging of Ocelaris made image interpretation intuitive and streamlined. The control provided by the unique deflectable tip and other modifications to the the catheter helped me efficiently cross challenging CTOs in the patients I treated, even those with previously failed interventions. Based on my early experience, I believe Ocelaris represents a significant advancement in the treatment of CTOs and look forward to performing more cases with the device."
Dr. Jaafer Golzar, Avinger's Chief Medical Officer who attended all of the cases, noted, "We were very pleased with the performance of Ocelaris in the hands of these skilled physicians, and appreciate Dr. Schwindt and Dr. Lichtenberg's continued leadership in Lumivascular. Ocelaris was used to successfully cross long, complex CTOs of various morphologies both above and below the knee. What we witnessed with our initial case experience could change our current paradigm of how we can safely cross long CTOs and redefine how we treat complex PAD."
Jeff Soinski, Avinger's President and CEO, commented, "This initial clinical experience with Ocelaris provides early validation of the potential impact this product can have for our image-guided CTO crossing franchise. While we will continue to gain feedback at select sites in Germany, our first cases provide us confidence that we remain on track for a 510(k) submission to the FDA in the first half of 2020."
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.
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 the benefits of Ocelaris, reduction in radiation exposure, increased clinical applicability of Ocelaris technology, market acceptance of Ocelaris, the timing of Avinger's submission of Ocelaris for 510(k) clearance and other statements that are not historical facts. 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 and in our other filings with the SEC, including, without limitation, our reports on Form 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, speak only as of the date hereof and reflect management's current estimates, projections, expectations and beliefs. Avinger disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avinger's expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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SOURCE: Avinger, Inc.