Avinger Gains 510(k) Clearance for Pantheris

Avinger received 510(k) clearance from the FDA for its lumivascular atherectomy system, Pantheris, an image-guided atherectomy device for treatment of peripheral artery disease.

The system includes a single balloon designed to allow blood flow occlusion and to treat blocked peripheral blood vessels using optical coherence tomography.

An in-process clinical trial is examining the device’s use for treating in-stent restenosis in lower extremity arteries.

Avinger said it plans to launch two versions at initial U.S. sites. The device previously received CE Mark approval in the European Union.