Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for treating patients with Peripheral Artery Disease (PAD), announces the enrollment of the first European patient in the CONNECT II global clinical trial. The first patient was enrolled this morning by Dr. Bernhard Reimers at Ospedale di Mirano in Mirano, Italy.
CONNECT II is multi-center, non-randomized 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, 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 visualize inside the arteries. Ocelot is the first CTO crossing catheter to incorporate Optical Coherence Tomography.
"This is a major milestone for Avinger and a true testament to the perseverance of all our employees and investors. Many people said we couldn´t do it," said Avinger´s Founder and CEO John B. Simpson, PhD, MD. "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."
In Mirano, Italy, Dr. Bernhard Reimers was also enthusiastic about commencing Avinger´s CONNECT II clinical trial. "With Ocelot´s first-ever advanced imaging technology, physicians treating PAD can see, in real-time, the intricacies of what they are doing inside the blocked arteries of their patients," he stated after enrolling the first trial patient in Europe. "I am a part of this trial because this new technology provides us a more scientific and controlled way to treat Peripheral Arterial Disease. This disease, if left untreated, often leads to amputation and death, but with Ocelot we believe many of these patients can now be saved."
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.
The study is designed to evaluate the safety and efficacy of Ocelot, which uses real-time OCT imaging as a navigation tool to traverse completely blocked arteries precisely where needed in order to restore blood flow back to normal.
As part of the trial, an independent group of physicians will review the angiography results to determine 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.
Avinger´s global product portfolio has already helped physicians treat more than 7,000 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.
About Avinger
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.
