REDWOOD CITY, Calif.–(BUSINESS WIRE)–Mar 7, 2013–Avinger, Inc., designer of therapeutic devices incorporating intravascular imaging, and pioneer of the lumivascular approach to treating vascular disease, announces the designation of the primary investigators for its upcoming global VISION pivotal study evaluating Pantheris.
Avinger is proud to announce that the primary co-investigators will be James Bennett, MD (Interventional Cardiologist), William Crowder, MD (Interventional Cardiologist) and Huey B. McDaniel, MD (Vascular Surgeon), all of Mississippi Heart and Vascular Institute at St. Dominic’s in Jackson, Mississippi and Arne Schwindt, MD (Vascular Surgeon) of St. Franziskus Hospital in Muenster, Germany.
The VISION trial is a multi-center, non-randomized global clinical study designed to evaluate the safety and efficacy of Pantheris, the first-ever image-guided atherectomy device for use in lumivascular procedures using real-time intravascular visualization technology called Optical Coherence Tomography, or OCT. Pantheris combines directional atherectomy capabilities with real-time visualization to remove plaque with precision from arteries affected by PAD.
Avinger expects to begin enrollment in VISION in the second half of 2013 pending regulatory review and approval.
Founded in 2007 by renowned cardiologist and medical device entrepreneur Dr. John B. Simpson, Avinger seeks to radically improve the treatment of vascular disease through the development of new technology and a new approach called lumivascular (lumi = light, vascular = artery). Lumivascular procedures use an interventional catheter system that incorporates light-based, radiation-free, intravascular imaging technology within the actual therapeutic device. This provides physicians with live, real-time, video-rate images of the inside of an artery during treatment, offering a variety of benefits for patients, physicians and hospitals. Already commercially available is Ocelot, the first line of devices using lumivascular technology, used to open totally occluded arteries in the legs. Avinger is currently developing a line of lumivascular atherectomy devices, called Pantheris, which will be used to remove plaque from the arteries affected by peripheral artery disease.