![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Avinger Image-Guided Atherectomy Device Gets CE Mark
Avinger Image-Guided Atherectomy Device Gets CE Mark
December 26, 2017
Avinger received a CE Mark for its image-guided Pantheris Lumivascular atherectomy system for treatment of peripheral artery disease.
The new device features a firmer shaft, a more robust nose cone that can store more tissue, an improved cutter design, and a simplified single balloon system for the occlusion of blood flow and device positioning, the company said.
It enables surgeons performing atherectomy, a minimally invasive surgery for PAD, to see from inside the artery during the procedure via Avinger’s Lightbox console instead of using x-rays.
Upcoming Events
-
21Oct