July 5, 2012 — Avinger Inc., a medical device manufacturer of multifunctional catheters for treating patients with peripheral artery disease (PAD), announced in June that it has successfully completed enrollment in its CONNECT II global clinical trial. PAD is a silent epidemic that affects 8 to 12 million adults in the United States and 30 million globally, and is the leading cause of amputation in patients over 50. A study published in the January 2012 issue of the American Heart Association journal Circulation claims that PAD is an unsung “pandemic” that afflicts even more women than men.
CONNECT II is a global clinical study that evaluated the safety and efficacy of Ocelot, the first interventional chronic total occlusion- (CTO) crossing catheter to use real-time intravascular imaging technology called optical coherence tomography (OCT). It allows physicians to cross, see and navigate inside totally blocked arteries in the legs of patients suffering from PAD.
“We are pleased to reach this significant milestone ahead of schedule and already see promising preliminary data collected,” said Avinger CEO and founder John B. Simpson. “We appreciate the patient participation and dedicated efforts of our employees, physician investigators and their research staffs. Together, we are now one step closer to bringing the Ocelot technology to patients who need it most.”
The company will present CONNECT II aggregate results at the VIVA conference in October 2012, file a 510K with the U.S. Food and Drug Administration (FDA) later this summer, and expects to receive 510K clearance in late 2012. In order to ensure Ocelot is available for use at U.S. CONNECT II sites during the 510K review period, Avinger has also requested FDA approval of an additional 125 patients to be enrolled and treated in a continued-access cohort.
CONNECT II is a prospective, multicenter, nonrandomized global clinical study that evaluated 100 PAD patients with femoropopliteal CTO lesions at 15 hospital and clinic sites, including two in the European Union, where Ocelot received CE mark in 2011. As part of the trial, an independent group of physicians are reviewing the angiographic results to determine Ocelot’s safety and efficacy.
For more information: www.avinger.com