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

Avinger Inc 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.