CONNECT II Study of Avinger's Ocelot Catheter Completes Enrollment

July 10, 2012—Avinger, Inc. (Redwood City, CA) announced that enrollment has been completed in the CONNECT II global clinical trial for the company's Ocelot crossing catheter. The Ocelot catheter provides integrated real-time intravascular imaging with optical coherence tomography for crossing chronic total occlusions in patients with peripheral arterial disease.

In its press release, the company stated that it expects to submit an application for 510(k) clearance for Ocelot to the US Food and Drug Administration later this year. The device received CE Mark approval in 2011 and is commercially available in Europe.

As previously reported in Endovascular Today, CONNECT II is a prospective, multicenter, nonrandomized global clinical study designed to evaluate the safety and efficacy of the Ocelot device in 100 peripheral arterial disease patients with chronic total occlusion lesions of the femoropopliteal artery. An independent group of physicians will review the angiography results to determine the Ocelot's crossing efficacy and safety. Coprincipal Investigators for the trial include Arne Schwindt, MD, in Muenster, Germany, and Matthew Selmon, MD, in Austin, Texas.

Avinger also announced the closing of a $33 million Series D funding round that will, in part, support the company's continued research and development of the Wolverine peripheral atherectomy catheter. Wolverine also incorporates intravascular imaging technology using optical coherence tomography. The funds will also facilitate worldwide sales of Avinger's existing product lines, including the Wildcat and Kittycat catheters, as well as planning for clinical trials for additional multifunctional catheters that incorporate intravascular imaging for the treatment of peripheral arterial disease, stated the company.