September 3, 2013 — Avinger Inc. has received CE Mark approval for Pantheris – a system that combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked arteries. 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 peripheral artery disease (PAD).
The first commercial Pantheris cases in Europe are to 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. IDE trial, 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,” Schwindt said. “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.”
Already commercially available in the United States is Ocelot, the first line of devices using optical coherence tomography (OCT) lumivascular technology, used to open totally occluded arteries in the legs. Avinger is expecting to begin its VISION trial in the United States later this year.
For more information: www.avinger.com