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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