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. Similar to Avinger’s highly successful Pantheris SV catheter for smaller vessels, Pantheris LV incorporates a proprietary design for plaque apposition without the need for a balloon to further improve procedural efficiency.
Jeff Soinski, Avinger’s President and CEO commented, “We continue to innovate rapidly to meet the needs of physician users and respond to the ever-changing market dynamics of PAD treatment. In combination with our recently launched Lightbox 3 imaging console, we believe that Pantheris LV and our new Tigereye ST CTO-crossing catheter, following clearance by FDA, will allow us to reach new physicians and increase usage of our products. Based on our previous history with 510(k) submissions of this nature, we expect to be in a position to launch Pantheris LV into U.S. distribution by the second half of 2023.”
“Pantheris LV brings important new features to Avinger’s image-guided atherectomy platform for the safe and highly effective treatment of PAD lesions in indicated arteries,” noted Dr. Jaafer Golzar, Avinger’s Chief Medical Officer. “We believe that the multiple design enhancements in Pantheris LV will drive efficiencies during the procedure, improve ease of use, and potentially address even more challenging lesions. Following FDA clearance, we are excited to introduce this widely anticipated technology to the endovascular community.”
Avinger’s Lumivascular technology incorporates an onboard image-guidance system to allow physicians, for the first time ever, to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence 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.
