Avinger Nabs CE Mark for System to Treat PAD

Avinger Inc. received CE mark approval for Pantheris, a system that combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked arteries. Atherectomy is a minimally invasive surgical method mainly used for removing atherosclerosis from a large blood vessel within the body. it is generally used to effectively treat peripheral arterial disease (PAD) of the lower extremities.

Pantheris is designed to remove the blockage while avoiding the disruption of normal arterial wall structures. This new type of image-guided atherectomy is referred to as lumectomy. Currently, approximately 200 million patients worldwide suffer from PAD.

“This is a major milestone for Avinger, and I couldn’t be more pleased with the progress we’ve made by getting Pantheris to market in Europe,” said founder and CEO, John B. Simpson, Ph.D., M.D. “Providing physicians with a tool to see the difference between the healthy artery wall and the disease itself while treating the vessel in real time—this is what I’ve been working towards for my entire career.”

The first commercial Pantheris cases in Europe will be performed by Arne Schwindt, M.D., of St. Franziskus Hospital in Muenster, Germany. Schwindt is also a co-principal investigator of Avinger’s U.S. investigational device exemption trial, called VISION. VISION is a multi-center, non-randomized global clinical study designed to evaluate the safety and efficacy of Pantheris.

“I’ve always been an advocate of using atherectomy as a minimally invasive way to treat patients with PAD,” said Schwindt. “And now with Pantheris, I won’t have to play the guessing game to decide what part of the artery needs to be treated. I’ll be able to see what I need to cut, and what should be left alone. The benefits of this advantage for my patients could be dramatic.”

Redwood City, Calif.-based Avinger was founded in 2007 by Simpson, a cardiologist and medical device entrepreneur. Simpson hopes to “radically change” the treatment of vascular disease through the development of new technology and a new approach called lumivascular (lumi = light, vascular = artery). Lumivascular procedures use an interventional catheter system that incorporates light-based, radiation-free, intravascular imaging technology within the actual therapeutic device. According to the company, this approach provides physicians with live, real-time, video-rate images of the inside of an artery during treatment, offering a variety of benefits for patients, physicians and hospitals.

Already commercially available is Ocelot, the first line of devices using lumivascular technology, used to open totally occluded arteries in the legs. Avinger officials expect to begin the VISION trial in the U.S. to support FDA clearance later this year.