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January 11, 2023
Avinger Submits 510(k) Filing for Pantheris LV Image-Guided Atherectomy System
January 11, 2023—Avinger, Inc. announced the submission of a 510(k) application to the FDA for Pantheris LV, the company’s next-generation intravascular image-guided atherectomy system for the treatment of peripheral artery disease in larger vessels, such as the superficial femoral artery and popliteal artery.
According to the company, Pantheris LV is designed to provide higher speed plaque excision for efficient removal of challenging occlusive tissue. The device offers 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.
Similar to Avinger’s Pantheris SV catheter for smaller vessels, which was launched in July 2019, Pantheris LV incorporates the company’s design for plaque apposition without the need for a balloon to further improve procedural efficiency, stated the company.
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