Avinger Stock Surges As Pantheris Scores FDA Approval For In-Stent Restenosis Indication

Avinger Inc AVGR received 510(k) clearance from the FDA for a new clinical indication for the Pantheris image-guided atherectomy system.
The clearance allows the Company to directly market Pantheris for in-stent restenosis (ISR) in the lower extremity arteries.
To support the 510(k) submission, Avinger provided data generated from the INSIGHT trial evaluating the safety and effectiveness of Pantheris for treating in-stent restenosis in lower extremity arteries.
In-stent restenosis occurs when a blocked artery previously treated with a stent becomes narrowed again, reducing blood flow.
Related Link: Avinger's Shares Move Higher As Pantheris Shows Safety, Efficacy For In-Stent Restenosis.
Price Action: AVGR shares are up 8.9% at $0.75 during the market session on the last check Wednesday.

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