“We are participating in CONNECT II because our patient, if treated with other current options on the medical market, could face amputation and death,” said Cawich. “With Avinger’s Ocelot, we believe this patient can be saved right now from both. The timing of this trial feels like a bit of miracle to our patient.” The Ocelot catheter uses OCT technology as a navigation tool with the goal of traversing chronic total occlusions more safely and effectively as part of a procedure to restore blood flow back to normal in the legs. It allows physicians, in real time, to see what is happening inside the arteries during the actual intervention, giving patients a better chance to receive the best treatment possible during a single hospital visit. “We hope that physicians using Ocelot can now help prevent even more leg amputations in people suffering from peripheral artery disease,” said John B Simpson, founder and CEO, Avinger. Conditional FDA approval to conduct this study was received on 27 January 2012. Co-principal investigators for the trial are Arne Schwindt, St. Franziskus Hospital, Muenster, Germany, and Matthew Selmon, Austin Heart Hospital, Austin, Texas, USA. |