REDWOOD CITY, Calif., - Dec. 1, 2015 - (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that it has filed a 510(k) pre-market notification with the U.S. Food and Drug Administration (FDA) for an enhanced version of its Pantheris™Catheter.
On October 14, 2015, Avinger received 510(k) clearance from the FDA for the Pantheris System for the treatment of patients with PAD. This new 510(k) application covers subsequent modifications to enhance the catheter, including improved ergonomics, physician controls and manufacturability. Based on the nature of the enhancements, the Company has requested that the FDA treat this application as a Special 510(k), which allows for initial review in as little as 30 days. However, the FDA retains broad discretion to extend the initial review by treating it as a traditional 510(k) or by requesting additional information not contained in the original filing.
"The VISION trial produced excellent clinical results and provided a wealth of experience and feedback on how we can make Pantheris even better. We have incorporated that important input into enhanced versions of Pantheris. Feedback on the enhancements from physicians using these devices under CE Mark in Europe has been very positive," said John B. Simpson, Ph.D., M.D., Founder and Executive Chairman of Avinger. "It remains our goal to introduce superior devices for treating patients with PAD. This 510(k) filing marks another essential step in that direction."
The Company successfully concluded the VISION IDE trial on Pantheris, exceeding all safety and efficacy endpoints in six-month follow-up data from the 130 patients treated per protocol in the study. Final data and analysis from the study were presented earlier this month at the Vascular Interventional Advances (VIVA) 2015 annual meeting by Arne Schwindt, M.D. of St. Franziskus Hospital in Muenster, Germany, one of the lead principal investigators. Data from this study was the basis for the 510(k) application Avinger submitted to the FDA on August 12, 2015.
About Avinger, Inc.
Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems for the treatment of patients with peripheral arterial disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the arms and legs. The Company's mission is to dramatically improve the treatment of vascular disease through the introduction of products based on its lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. Avinger's current lumivascular products include the Lightbox™ imaging console, the Ocelot™ family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs, and Pantheris™, the first-ever image-guided atherectomy device, designed to precisely remove arterial plaque in PAD patients. For more information, please visit the Company's website at www.avinger.com.
"Avinger," "Pantheris" and the Avinger logo are registered trademarks of Avinger, Inc.
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 timing of regulatory approvals and commercial launch of Pantheris. 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; ability to demonstrate the benefits of our lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results including our VISION Trial; potential exposure to third-party product liability and intellectual property 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" in our Form 10-Q filing made with the Securities and Exchange Commission on November 12, 2015. These forward-looking statements speak only as of the date hereof. Avinger disclaims any obligation to update these forward-looking statements.
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