Avinger has received CE mark approval for Pantheris—a system that combines directional atherectomy capabilities with real-time intravascular visualisation 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.
“This is a major milestone for Avinger, and I could not be more pleased with the progress we have made by getting Pantheris to market in Europe,” said founder and chief executive officer John B Simpson. “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 have been working towards for my entire career.”
The first commercial Pantheris cases in Europe are to be performed by Arne Schwindt, St Franziskus Hospital in Münster, Germany. Schwindt is also a co-principal investigator of Avinger’s US IDE trial, VISION. VISION is a multicentre, non-randomised global clinical study designed to evaluate the safety and efficacy of Pantheris.
“I have always been an advocate of using atherectomy as a minimally invasive way to treat patients with peripheral arterial disease,” said Schwindt. “And now with Pantheris, I will not have to play the guessing game to decide what part of the artery needs to be treated. I will 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.”