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November 7, 2012
FDA Clears Avinger's Ocelot System
November 8, 2012—Avinger Inc. (Redwood City, CA) announced that the US Food and Drug Administration has granted marketing clearance for the company's Ocelot system. The Ocelot catheter, supported by the Lightbox console, incorporates optical coherence tomography to allow interventionists to navigate and cross chronic total occlusions (CTOs) in the legs of peripheral arterial disease patients using a real-time cross-sectional image of the artery.
According to Avinger, FDA clearance was supported by the results of the company's CONNECT II global clinical trial. CONNECT II was composed of 122 patients in Europe and the United States and was designed to evaluate the safety and efficacy of the Ocelot catheter for crossing CTOs.
In June 2012, Avinger successfully completed enrollment in CONNECT II, in which the Ocelot system demonstrated a CTO crossing success of 97% with 98% freedom from major adverse events. In October, CONNECT II's Coprincipal Investigator Matthew Selmon, MD, presented the presented the data at the VIVA 2012: Vascular Interventional Advances Conference 2012 in Las Vegas, Nevada.
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