Avinger Obtains FDA 510(k) Clearance for Pantheris LV Image-Guided Atherectomy System

Thursday, June 08, 2023

Avinger, Inc.announced today that it has obtained 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Pantheris® LV, its advanced image-guided atherectomy system for treating peripheral artery disease (PAD) in larger vessels. The system is designed for use in vessels such as the SFA and popliteal arteries, which are commonly targeted in PAD procedures.

Pantheris LV offers multiple innovative features and benefits to physicians, including higher cutter speeds for more efficient removal of challenging occlusive tissue and a proprietary design that improves plaque apposition, enhancing procedural efficiency. The system also incorporates user-friendly enhancements, including improved torque feedback, guidewire management, and tissue packing and removal.

Avinger plans to launch Pantheris LV on a limited scale by the end of the current quarter, with full commercial availability expected in the U.S. in the second half of 2023.
Jeff Soinski, President and CEO of Avinger, expressed enthusiasm for the FDA clearance and the potential of Pantheris LV to expand the company's platform. He highlighted the combined strength of Pantheris LV with other recently cleared devices, such as the Tigereye ST image-guided CTO crossing platform and the portable Lightbox 3 imaging system. These advancements enable Avinger to offer an upgraded product portfolio and reach new interventional physicians, driving the adoption of their PAD treatment technology.

Dr. Jaafer Golzar, Avinger's Chief Medical Officer, shared his excitement about the impact of Pantheris LV on workflow efficiency and clinical outcomes. He emphasized the enhancements made across the product portfolio, including promising data on Pantheris for treating in-stent restenosis and complex below-the-knee lesions. Dr. Golzar believes that the Lumivascular platform, including Pantheris LV, presents a compelling case for interventionalists to incorporate it into their treatment algorithms.

Avinger's Lumivascular technology integrates an onboard image-guidance system that utilizes optical coherence tomography (OCT) for real-time visualization inside the artery during atherectomy or CTO-crossing procedures. The system provides high-resolution intravascular OCT images displayed on Avinger's Lightbox console, allowing physicians to guide their therapy accurately. Unlike other devices that rely solely on X-ray images and tactile feedback, the Lumivascular approach enables precise navigation and effective treatment of PAD lesions while minimizing radiation exposure for healthcare workers and patients.



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