REDWOOD CITY, Calif., and NEW ORLEANS, May 31, 2017 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ: AVGR ), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular™ technology.
The VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris® system to perform directional atherectomy while, for the first time ever, allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported U.S. Food and Drug Administration (FDA) 510(k) clearance of the system in 2016.
Twenty four (24) month follow-up results from 89 patients were presented by Patrick Muck, M.D., Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, at New Cardiovascular Horizons (NCVH) in New Orleans, Louisiana. This includes an additional 34 patients beyond the interim data set presented on January 25, 2017. Data presented today remain subject to adjustment based on final statistical analysis and review by the study’s clinical events committee.
Key highlights of the presentation include:
- Kaplan Meier survival probability measured 82% freedom from target lesion revascularization (TLR) at 12 months by patient (84% by lesion) and 74% freedom from TLR at 24 months by patient (76% by lesion)
- The VISION 24-month Kaplan Meier freedom from target lesion vascularization at 24 months remained stable between 18 and 24 months
- Statistically significant improvements in ankle brachial index (ABI) and Rutherford classification at 30 days were maintained through 24 months
- A majority of lesions were treated using standalone optical coherence tomography (OCT) guided atherectomy with the Pantheris catheter, with only 9.6% (n=19/198) receiving adjunctive drug coated balloon (DCB) therapy and only 5% (n=10/198) receiving adjunctive stent therapy
“The complete VISION 24-month data demonstrates positive longer-term sustained results for patients treated with Pantheris, and importantly, these patients have largely avoided the need for a repeat procedure in a two-year timeframe,” commented Dr. Muck. “Considering that the outcomes were generated at the hands of brand new users with a first-generation clinical trial device, such positive results represent an important step forward for Pantheris in the clinical setting.”
“These excellent results continue to reinforce our enthusiasm for the Pantheris System,” said Dr. John B. Simpson, Avinger’s Founder and Executive Chairman. “We are gratified that Lumivascular technology is improving the lives of patients with PAD, including many facing amputation. In the meantime we continue to refine the system, with Pantheris 3.0, our next-generation atherectomy catheter, and a lower-profile Pantheris device currently in development.” About Avinger, Inc. Founded in 2007, Avinger, Inc. is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based systems that diagnoses and treats patients with peripheral arterial disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through their Lumivascular platform which currently consists of the Lightbox imaging console, the Ocelot family of catheters designed for chronic total occlusions (CTOs), and Pantheris designed for atherectomy. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com .
Public Relations Contact: Phil Preuss Avinger, Inc. (650) 241-7900 pr@avinger.com Investor Contact: Matt Ferguson Avinger, Inc. (650) 241-7917 ir@avinger.com
