Avinger announces 510(k) filing for new pantheris in-stent restenosis indication

Redwood city, ca / accesswire / july 6, 2021 / avinger, inc. (nasdaq:avgr), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of peripheral artery disease (pad), today announced the submission of a 510(k) application to the u.s. food & drug administration (fda) for a new pantheris clinical indication for the treatment of in-stent restenosis (isr) in the lower extremity arteries. highlighting the importance of this submission, jeff soinski, avinger's president and ceo commented, "we are extremely pleased with this milestone and the initial clinical data generated from the insight trial that supports the 510(k) submission.
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