Avinger Inc. announced the enrollment of the first European patient in the CONNECT II global clinical trial. The first patient was enrolled by Dr. Bernhard Reimers at Ospedale di Mirano in Mirano, Italy.
CONNECT II is a multicenter, nonrandomized global clinical study designed to evaluate the safety and efficacy of Ocelot, Avinger’s first therapeutic catheter to incorporate the real-time intravascular imaging technology called optical coherence tomography (OCT). Currently CE-marked, Ocelot is designed for crossing completely blocked arteries, or chronic total occlusions (CTOs), in the legs while simultaneously using OCT to visualize inside the arteries. Ocelot is the first CTO-crossing catheter to incorporate OCT.
“Ocelot and CONNECT II is our first step toward incorporating intravascular imaging into therapeutic catheters. We truly believe this will revolutionize the treatment of vascular disease and amputation prevention,” said Avinger founder and CEO John B. Simpson.
As part of the trial, an independent group of physicians will review the angiography results to determine crossing efficacy and safety. Conditional U.S. Food and Drug Administration (FDA) approval to conduct the study was received Jan. 27, 2012. Co-principal investigators for the trial include Arne Schwindt of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon, M,D,, Austin Heart Hospital in Austin, Texas.
For more information: avinger.com