Avinger, Inc. announced the company has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Pantheris LV, its next-generation image-guided atherectomy system for the treatment of peripheral artery disease (PAD). Pantheris LV is designed for treatment in larger vessels, such as the SFA and popliteal arteries, where the majority of PAD procedures are performed today. Pantheris LV offers multiple new features and benefits to physician users, including higher cutter speeds for more efficient removal of challenging occlusive tissue and a proprietary design for plaque apposition to improve procedural efficiency.

Pantheris LV incorporates several additional features to streamline and simplify user-operation, including design improvements for enhanced torque feedback, guidewire management, and improved tissue packing and removal. Avinger 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 U.S. in the second half of 2023. Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called opticalherence tomography, or OCT.

During the procedure, high-resolution intravascular OCT images are displayed on Avinger's Lightbox console in real-time to guide therapy. Physicians performing therapeutic procedures with other devices must rely solely on X-ray images and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions to deliver safe and effective outcomes, without exposing healthcare workers and patients to the negative effects of ionizing radiation.