Avinger announces 510(k) filing of pantheris lv

Pantheris lv represents the next-generation of onboard image-guided technology for the treatment of peripheral artery disease redwood city, ca / accesswire / january 11, 2023 / 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 company submitted a new 510(k) application to the u.s. food & drug administration (fda) for pantheris lv, its next-generation image-guided atherectomy system for the treatment of larger vessels, such as the sfa and popliteal arteries, where the majority of pad procedures are performed today. pantheris lv offers multiple benefits to physician users, including higher speed plaque excision for efficient removal of challenging occlusive tissue and multiple features to streamline and simplify user-operation, including enhanced tissue packing and removal, a radiopaque gauge to measure volume of plaque removal during the procedure, and enhanced guidewire management.
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