Benzinga | Jul 6, 2021 10:26AM EDT

Avinger Files US Application For New Pantheris In-Stent Restenosis Indication

* Avinger Inc (NASDAQ:AVGR) has submitted a 510(k) application to the FDA for a new Pantheris clinical indication for the treatment of in-stent restenosis (ISR) in the lower extremity arteries.

* To submission is based on the INSIGHT trial that evaluated the safety and effectiveness of the Pantheris atherectomy system for treating in-stent restenosis in lower extremity arteries.

* Pantheris atherectomy devices are part of the Lumivascular platform that allows physicians to see from inside the artery during an atherectomy procedure using an optical coherence tomography imaging modality.

* Price Action: AVGR shares are up 3.6% at $1.15 during the market session on the last check Tuesday.