Results of Clinical Study Support Avinger Ocelot OCT Catheter for Crossing CTOs

October 11, 2012—Avinger, Inc. (Redwood City, CA) announced results for its CONNECT II global clinical trial. CONNECT II's Coprincipal Investigator Matthew Selmon, MD, from the Heart Hospital of Austin in Austin, Texas, presented the data at the VIVA 2012: Vascular Interventional Advances Conference 2012 in Las Vegas, Nevada. Arne Schwindt, MD, of St. Franziskus Hospital in Muenster, Germany was the Coprincipal Investigator with Dr. Selmon.

CONNECT II was a 2012 global clinical study that evaluated the safety and efficacy of the company's Ocelot catheter for crossing chronic total occlusions (CTOs) in patients with peripheral arterial disease (PAD). The Ocelot catheter incorporates optical coherence tomography (OCT) to allow interventionists to navigate and cross CTOs in the legs of PAD patients using a real-time cross-sectional image of the artery.

As summarized in Avinger's press release, the trial evaluated the safety and effectiveness of the Ocelot system in crossing femoropopliteal CTO lesions. It was a prospective, multicenter, nonrandomized study conducted under a US Food and Drug Administration (FDA) investigational device exemption. The study enrolled 122 patients, including 22 roll-in patients, at 15 investigational sites in the United States and European Union from February 23 to June 7, 2012. There were two additional investigational sites that did not enroll patients. Enrollment is continuing through the Continued Access phase of the study until the Ocelot device receives FDA clearance, which the company expects by the end of the year.

The company announced that the Ocelot system successfully crossed the target CTO lesion in 97% (97/100) of primary cohort subjects with an overall major adverse event rate of 2% (2/98), indicating both the primary safety and efficacy endpoints were statistically met. Both endpoints were assessed through independent angiographic review.

“These results are impressive and exciting,” commented Dr. Selmon in the company's press release. “Having the ability to visually navigate, in real time, inside of the artery during these procedures is going to change the way physicians cross CTOs in order to treat severe PAD.”