First Patients Treated Successfully in Australia with Image-Guided CTO-Crossing Device
REDWOOD, CA / ACCESSWIRE / July 8, 2019 / Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the commercial launch of its Ocelot image-guided chronic total occlusion (CTO) crossing system in Australia. As part of the Company's exclusive distribution agreement with Diverse Devices Pty Ltd. for Avinger's proprietary Lumivascular products in Australia, Ocelot completed the registration process with the Therapeutic Goods Administration (TGA) and is included on the Australian Register of Therapeutic Goods, which permits distribution in Australia.
Dr. Christopher Delaney, a highly-experienced vascular surgeon, performed the first two cases with Ocelot at Flinders Medical Centre in Bedford Park, Australia. Dr. Delaney successfully crossed mild-to-severely calcified CTO lesions of 60mm and 200mm in length in the larger vessels of the peripheral arteries. Following his initial experience using Ocelot, Dr. Delaney commented, "Chronic total occlusions represent a significant clinical challenge for interventionists, as they are associated with lower procedural success and higher potential complications. If unsuccessful with an endovascular approach, patients with CTOs may require referral to bypass surgery or even amputation. With Ocelot, I was able to successfully traverse the lesions and subsequently deliver a minimally invasive therapy for these two patients, with a great final outcome and avoidance of surgery or amputation."
"We are excited to broaden the footprint of our image-guided platform in Australia through our relationship with Diverse Devices," commented Jeff Soinski, Avinger's President and CEO. "We believe the addition of Ocelot for physicians in Australia will make a positive impact on the treatment of vascular disease in this important new market. We are thrilled that Dr. Delaney achieved such positive results for these first two patients using our Lumivascular technology and appreciate his pioneering efforts with Ocelot in Australia."
Lumivascular technology allows physicians, for the first time ever, to see the inside of 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 images, 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 commercial prospects in a new market, potential product introductions, and reliance on a third party partner for distribution of Avinger products. 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 8, 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.
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SOURCE: Avinger, Inc.
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