REDWOOD CITY, Calif., Aug. 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, announced it will file a submission today with the U.S. Food and Drug Administration (FDA) for 510(k) clearance to market its Pantheris image-guided atherectomy device for the treatment of patients with peripheral arterial disease (PAD).
Dr. John B. Simpson, Avinger's Founder and Executive Chairman, commented, "The favorable data we have seen in our VISION Trial is critical to our goal of bringing Pantheris to market. As previously reported, our 30-day data surpassed the primary VISION efficacy endpoint. Data collection continues for our six-month primary safety endpoint. Based on the six-month data collected to date and in collaboration with FDA, we are allowed to submit our 510(k) application earlier than anticipated. We are hopeful this early filing will lead to clearance for Pantheris in the U.S. by year-end, which would enable a U.S. launch of Pantheris in early 2016."
Pursuant to Section 510(k), the FDA has 90 days in which to clear the Class II medical device for commercial distribution or to seek additional information. Avinger anticipates that the follow-up on all remaining VISION patients will be completed and provided to FDA in advance of the end of the 90-day review cycle. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States.
Avinger expects to present full results from the VISION Trial at a major clinical conference in the fourth quarter of this year.
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. For more information, please visit the Company's website at www.avinger.com.
Forward-Looking Statements
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 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 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 August 12, 2015. These forward-looking statements speak only as of the date hereof. Avinger disclaims any obligation to update these forward-looking statements.