Primary Safety and Efficacy Endpoints Achieved
Target Lesion Revascularization Rate Equals 10.8%
SAN FRANCISCO, Oct. 13, 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 interim six-month results for its VISION clinical trial. VISION is designed to evaluate the safety and effectiveness of the 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. VISION results were presented by Arne Schwindt, M.D. of St. Franziskus Hospital in Muenster, Germany, at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 medical meeting. Six-month results presented today were from an interim analysis of 93 patients out of the 130 patients treated per protocol in the study. Data from this interim cohort was the basis for the 510(k) application Avinger submitted to the U.S. Food and Drug Administration (FDA) on August 12, 2015. The Company anticipates that six-month data from all 130 patients will be presented at a major medical meeting in November.
VISION results demonstrate successful achievement of all primary and secondary safety and effectiveness endpoints. The primary safety endpoint, related to incidence of major adverse events (MAEs), was 21.5% in the 93-patient interim cohort, measuring below the pre-defined study limit of 43.2%. The safety results include zero Pantheris-related dissections or perforations across all lesions treated. Importantly, the interim cohort, representing 72% all of patients treated, demonstrates a promising target lesion revascularization (TLR) rate through six-month follow-up of 10.8%. As previously reported, the primary efficacy endpoint of residual stenosis less than or equal to 50% following Pantheris treatment alone was achieved in 96.3% (158/164) of lesions, significantly outperforming the pre-defined study goal of 87%.
Commenting on the VISION trial results, principal investigator Dr. Arne Schwindt stated, "I have been impressed with the Pantheris technology, especially the amount of additional information and precision available during the intervention. The high efficacy and low TLR results through six months further confirm my belief that the precision offered through real time OCT visualization at the point of therapy will have a lasting effect on patient outcomes. This new tool will make atherectomy a safer and more effective procedure for patients with PAD."
Additional metrics from the VISION trial point to the standalone therapeutic capability of Pantheris with 55% of lesions being treated with Pantheris alone. Importantly, placement of a stent following treatment with Pantheris was minimized to 4% across all lesions treated (n=7).
On average, following treatment using Pantheris with or without adjunctive therapy, arterial stenosis was reduced from 78.7 ± 15.2% pre-treatment to 22.2 ± 9.8% post-treatment, which represents a 70.5% reduction in stenosis. These results correlate with statistically significant improvements in both ankle-brachial index (ABI) and Rutherford classification at six months.
In addition to positive clinical outcomes, histologic analysis of the VISION trial atherectomy specimens highlights the tremendous precision that real-time OCT guidance enables during directional atherectomy. Across all lesions treated, the average percent area of adventitia in tissue removed was 1.0%. This result confirms that real-time imaging provides the feedback necessary for physicians to treat PAD without damaging normal arterial structures such as adventitia, which has been shown to potentiate restenosis. Histologic results are expected to be a key differentiator in the VISION trial. These findings will be used to further support the Avinger hypothesis that minimizing arterial wall disruption during therapy promotes reduced adjunctive treatments, improved long-term arterial patency, and ultimately minimizes the need for re-intervention.
"These interim results from the VISION trial are a testament to the game-changing lumivascular technology and years of dedication by both our physician partners and the Avinger team," said John B. Simpson, Ph.D., M.D., Founder and Executive Chairman of Avinger. "As the study results demonstrate, the VISION investigators were able to achieve unprecedented levels of control and precision in the Pantheris atherectomy procedures, which I believe will radically improve outcomes for patients suffering from PAD."
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 the safety and efficacy of Pantheris 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 plans to present the data from the VISION study, the results and impact of such data, planned regulatory and commercialization activities, expected histology results 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, 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.