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Avinger secures CE Mark approval for lumivascular atherectomy device

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.