June 7, 2023

Avinger’s Pantheris LV Image-Guided Atherectomy System Receives FDA 510(k) Clearance

June 7, 2023—Avinger, Inc. announced it has received 510(k) clearance from the FDA for Pantheris LV, its next-generation image-guided atherectomy system for the treatment of peripheral artery disease (PAD) in larger vessels, such as the superficial femoral artery and popliteal artery. The company intends to initiate a limited launch of Pantheris LV by the end of the current quarter with plans to expand to full commercial availability in the United States in the second half of 2023.

According to Avinger, Pantheris LV’s new features include higher cutter speeds for more efficient removal of challenging occlusive tissue and a design for plaque apposition to improve procedural efficiency. The Pantheris LV streamlines and simplifies user operation with design improvements for enhanced torque feedback, guidewire management, and improved tissue packing and removal, noted the company.

Avinger’s Lumivascular technology incorporates an onboard image-guidance system that allows physicians to see inside the artery during an atherectomy or chronic total occlusion-crossing procedure by using optical coherence tomography.

On April 26, 2023, Avinger, announced FDA 510(k) clearance for Tigereye ST, a next-generation image-guided CTO crossing system.

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June 7, 2023

Avinger’s Pantheris LV Image-Guided Atherectomy System Receives FDA 510(k) Clearance

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