CONNECT II is a multi-center, non-randomized global clinical study designed to evaluate the safety and efficacy of Ocelot, the first-ever CTO crossing catheter to use real-time intravascular imaging technology called Optical Coherence Tomography, or 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 navigate inside the arteries.
"We hope that physicians using Ocelot can now help prevent even more leg amputations in people suffering from PAD," said Avingers founder and CEO John B. Simpson, PhD, MD. "The team here at Avinger has been working really hard and Im excited to see our efforts now go directly towards helping these patients."
The Ocelot catheter uses OCT technology as a navigation tool with the goal of traversing CTOs 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 whats 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 are participating in CONNECT II because our patient, if treated with other current options on the medical market, could face amputation and death," said Dr. Ian Cawich at the Arkansas Heart Hospital. "With Avingers 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."
More about CONNECT II Clinical Trial
CONNECT II is a prospective, multi-center, non-randomized global clinical study that will evaluate 100 PAD patients with femoropopliteal CTO lesions at 17 sites, including three in the EU, where Ocelot received CE Mark in 2011.
As part of the trial, an independent group of physicians will review the angiography results to determine Ocelots crossing efficacy and safety.
Conditional FDA approval to conduct this study was received on January 27, 2012. Co-principal investigators for the trial include Arne Schwindt, MD of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon, MD, Austin Heart Hospital in Austin, TX.
Avingers global product portfolio has already helped physicians treat more than 7,900 patients suffering from PAD. Major causes of PAD include smoking, obesity, high cholesterol, high blood pressure, diabetes, inactivity, and poor diet. It is estimated that PAD currently affects between 8 and 12 million adults in the United States and is the leading cause of amputation in patients over 50.
Founded in 2007 by renowned cardiologist and medical device entrepreneur Dr. John B. Simpson, Avinger develops next-generation catheter-based technologies for the treatment of peripheral artery disease (PAD). Leveraging core competencies in medical device catheter engineering and intravascular Optical Coherence Tomography (OCT), Avinger markets Wildcat and Kittycat catheters, and recently received CE Mark to market Ocelot, the first ever real-time OCT crossing catheter. www.avinger.com