Three patients successfully treated using next generation image-guided atherectomy device with enhanced tissue removal capacity for treatment of peripheral artery disease
REDWOOD CITY, Calif., March 29, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in Münster, Germany, successfully treated the first three patients with the extended nosecone version of the next generation Pantheris Lumivascular atherectomy system (A400EX). This product is a line extension of the existing next generation platform, with a longer nosecone that enhances the plaque removal capacity of the device in addition to the feature improvements of the next generation of devices. This new device qualifies for commercial sale in the European Union (EU) under the existing CE Marking for Pantheris.
The extended nosecone increases the storage capacity of the Pantheris system by approximately 75%, which should translate to increased procedural efficiency, particularly in long, diffuse lesions with significant plaque burden. Dr. Schwindt, who has now performed 21 cases across all platforms of the next generation Pantheris, used the A400EX to treat a variety of challenging lesion types, including in-stent restenosis (ISR). This device is available in limited supply for commercial sale in select EU countries; it is not available commercially in the United States at this time.
Dr. Schwindt noted, “Despite the difficult nature of these particular interventions, I was able to safely and effectively achieve positive outcomes for these patients using the new version of Pantheris with the extended nosecone. I am excited to continue to use this technology in lesions with higher plaque burden, and continue to see the added benefit of the design improvements incorporated into the next generation Pantheris platform.”
“We appreciate Dr. Schwindt’s continued partnership with us in our objective to improve physician user experience with our technology while continuing to generate positive patient outcomes,” said Jeff Soinski, Avinger’s president and CEO. “Dr. Schwindt’s feedback will continue to be invaluable as we launch our Pantheris next generation platform in additional sites both in the EU and in the US, once we receive FDA 510(k) clearance.”
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy 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). 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 performance of our next-generation device and its potential FDA clearance in the United States. 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; 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 Form 10-Q and offering prospectus on Form S-1 filed with the Securities and Exchange Commission on November 14, 2017 and February 15, 2018, respectively. 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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