Avinger, a manufacturer of multifunctional catheters, has received CE Mark approval for Pantheris, a lumectomy catheter designed to remove the blockage while avoiding the disruption of normal arterial wall structures.
This lumivascular atherectomy device combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked arteries.
Pantheris is reportedly the first lumectomy catheter for image-guided atherectomy to treat patients with peripheral artery disease.
Avinger founder and CEO Dr John B Simpson noted this as a major milestone for Avinger and is pleased with progress of Pantheris entry into European market.
"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," Dr Simpson added.
The company has also designed VISION, a multi-center, non-randomized global clinical study to evaluate the safety and efficacy of Pantheris.
Avinger’s VISION co-principal investigator Dr Arne Schwindt will perform the first commercial Pantheris cases in Europe.
"I’ve always been an advocate of using atherectomy as a minimally invasive way to treat patients with PAD," Dr Schwindt added.