REDWOOD CITY, Calif., March 12, 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 completed enrollment of its VISION clinical study, which is designed to evaluate the safety and efficacy of the Company's Pantheris™ system. The Pantheris catheter is the only device to combine directional atherectomy with real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
In July 2014, the U.S. Food & Drug Administration (FDA) granted Avinger an investigational device exemption, or IDE, for Pantheris and the Company commenced enrollment of a 133-patient trial in the U.S. and Europe. The Company expects to present interim 30-day data in the second quarter and six-month data in the fourth quarter of 2015. Primary safety and efficacy endpoint analysis results will be used to support a 510(k) application with the FDA, anticipated to be filed in the second half of 2015.
"Completing enrollment for the VISION trial is a significant clinical milestone for Avinger and more importantly a key development for patients suffering from PAD. We are extremely grateful for the collaboration of our clinical investigators who supported timely enrollment in this ground breaking study," said John B. Simpson, Ph.D., M.D., Founder and Executive Chairman of Avinger. "Pantheris is designed to provide physicians with a better understanding of arterial narrowings in real time, which we believe will significantly improve PAD patient outcomes. We believe we are on track to meet or exceed the required primary safety and efficacy endpoint requirements of the study, and plan on filing our 510(k) application for Pantheris later this year after six month follow-up data is available."
"Participation in the VISION trial has been not only a privilege but an eye-opening experience. Never before have we had this much information available, in real-time, about the disease and structures on the inside of the artery," said lead enroller, Barry Tedder, M.D., Interventional Cardiologist of St. Bernards Hospital, Jonesboro, Arkansas. "I believe that the Pantheris catheter for atherectomy and the lumivascular approach more broadly have the potential to revolutionize the treatment of vascular disease."
VISION is a non-randomized, prospective, global, single-arm clinical trial that is evaluating the safety and effectiveness of the Pantheris catheter to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. As part of the trial, an independent group of physicians will review the angiography results for each patient treated to determine Pantheris' efficacy. An independent Clinical Events Committee (CEC) is reviewing and adjudicating all primary safety endpoint data.
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 available in this market. Avinger's current lumivascular products include the Lightbox™ imaging console and Ocelot™ family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs. The Company is also developing Pantheris™, an image-guided atherectomy device, designed to precisely remove arterial plaque in PAD patients. Pantheris is currently undergoing a U.S. clinical trial intended to support a 510(k) submission to the FDA in the second half of 2015. For more information, please visit the Company's website at 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 market opportunity for our products, progress towards achieving clinical endpoints and planned regulatory and commercialization activities. 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, which has not been approved and may not be approved; the outcome of clinical trial results including our VISION clinical 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 the company's 424(B)(4) filing made with the Securities and Exchange Commission on January 30, 2015 in connection with the company's initial public offering. These forward-looking statements speak only as of the date hereof. Avinger disclaims any obligation to update these forward-looking statements.