In-Stent Restenosis Treatment Indication Approved in Europe for Avinger's Pantheris Lumivascular Atherectomy System


September 26, 2017—Avinger, Inc. announced CE Mark approval for treating in-stent restenosis with the company's Pantheris Lumivascular atherectomy system.

According to the company, the system provides operators with intravascular visualization combined with a directional mechanism so they have the information and precision needed to treat only diseased tissue without contacting the stent struts or adventitia.

The image-guided, catheter-based Lumivascular platform diagnoses and treats patients with peripheral artery disease. The platform consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion catheters, and the Pantheris family of atherectomy devices.

Avinger noted that Lumivascular technology allows physicians to see from inside the artery during a directional atherectomy procedure by using optical coherence tomography that is displayed on the Lightbox console. Using real-time optical coherence tomography image guidance, physicians can more accurately navigate their devices to treat peripheral artery disease without exposing health care workers and patients to radiation.


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