Avinger, Inc. Announces Outcomes from the Pivotal VISION Study of Lumivascular Technology for Peripheral Artery Disease
January 26, 2017 at 02:31 am IST
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Avinger, Inc. 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. Kaplan Meier survival probability measured 86% freedom from target lesion revascularization (TLR) at 12 months and 82% freedom from TLR at 24 months Zero (0%) amputations through 24 months. Statistically significant improvements in ankle brachial index (ABI) and Rutherford classification at 30 days 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.
Avinger, Inc. is a commercial-stage medical device company. The Company designs, manufactures, and sells real-time, image-guided, minimally invasive catheter-based systems that are used by physicians to treat patients with peripheral artery disease (PAD). Its Lumivascular platform includes the Lightbox real-time imaging console, the Ocelot and Tigereye family of catheters, which are image-guided catheters designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion (CTO), and the Pantheris family of catheters, its image-guided atherectomy family of catheters designed to allow physicians to remove arterial plaque in PAD patients. Its Pantheris is a single-use product and provides physicians with the ability to see a cross-sectional view of the peripheral artery to guide the removal of blockages throughout the procedure. It has also developed a line extension of its Pantheris image-guided atherectomy platform, Pantheris Small Vessel (SV).
AVINGER, INC. 
