REDWOOD CITY, Calif., Nov. 2, 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 its Pantheris™ system has achieved all safety and efficacy endpoints in six-month follow-up data for its VISION IDE clinical trial. VISION was designed to evaluate the safety and effectiveness of Pantheris 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.
VISION results from the 130 patients treated per protocol in the study were presented today 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.
Final VISION trial results demonstrated:
- Primary efficacy endpoint of residual stenosis less than or equal to 50% following Pantheris treatment was achieved in 96.3% (158/164) of lesions, significantly outperforming the pre-defined study goal of 87%;
- Target lesion revascularization (TLR) rate of 8.0% and overall major adverse event (MAE) rate of 17.6% through six-month follow-up, measuring below the pre-defined study limit for MAEs of 43.2%;
- Zero clinically significant dissections, perforations, or late aneurysms related to Pantheris;
- Statistically significant improvement across all patients in both blood flow measurement (Ankle Brachial Index) and symptom-based outcomes (Rutherford Classification);
- Stent placement in only 4% of lesions following treatment with Pantheris;
- Six-month TLR of 6.5% in chronic total occlusion (CTO) subgroup (n=31) with only one instance of adjunctive stent placement; and
- Only 1% adventitia in tissue removed, on average, across all lesions treated.
Commenting on the results of the VISION trial, Dr. Schwindt said, "The positive final data supports the interim results achieved in the first 93 patients, and further highlights the benefit Pantheris offers in treating patients with PAD. Patients experienced no dissections, no perforations, and no late aneurysms related to Pantheris treatment. Moreover, histology confirms the precision of Optical Coherence Tomography (OCT) guidance to aid in the removal of plaque from diseased lower extremity arteries."
The average percent area of adventitia, an indicator of arterial wall disruption, in the atherectomy tissue samples collected was just 1.0% across all lesions treated and analyzed for histology. This histologic analysis highlights the tremendous precision that real-time OCT guidance enables during directional atherectomy, and confirms that real-time imaging provides the feedback necessary for physicians to treat PAD without damaging normal arterial structures such as adventitia.
"Through all aspects of the VISION trial, starting with design, then enrollment, then execution and follow-up, I personally could not have predicted a better outcome. For sure, the results reflect what happens when truly unique devices are investigated by serious investigators working in a collaborative effort with the FDA," said John B. Simpson, Ph.D., M.D., Founder and Executive Chairman of Avinger. "Never before have I been involved in a trial with such consistently positive outcomes. I am confident that we have opened the door on the development of technology that will significantly improve the treatment of peripheral arterial disease."
On October 14, 2015, Avinger received FDA clearance of Pantheris based on an interim analysis of 93 patients. The final data analysis of all patients treated per protocol (n=130) has been filed with the FDA to supplement the 510(k) clearance.
VISION is a non-randomized, prospective, global, single-arm clinical trial that is evaluating the safety and effectiveness of the PantherisTM system to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. The study enrolled 134 patients and includes follow-up data collection review by independent third parties at thirty days and six months.
Pantheris is the first-ever image-guided atherectomy device using real-time intravascular visualization technology. Pantheris is the subject of the VISION IDE trial, a ground-breaking study designed to evaluate its safety and efficacy for directional atherectomy in the peripheral arteries, while allowing physicians to use high resolution Optical Coherence Tomography (OCT) intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
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 clinical benefits of Pantheris and adoption of Pantheris for treatment of PAD. 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 August 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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