Avinger Receives 510(k) Clearance for Pantheris LV Image

Published: Jun 07, 2023

REDWOOD CITY, CA / ACCESSWIRE / June 7, 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 vascular disease, today 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.

Jeff Soinski, Avinger's President and CEO commented, "We are thrilled to receive FDA clearance for Pantheris LV and are excited about the potential for this advanced new device to expand penetration of our platform. Pantheris LV, in combination with the recently cleared Tigereye ST image-guided CTO crossing platform and portable Lightbox 3 imaging system, gives Avinger an upgraded and high-powered product portfolio to reach new interventional physicians and drive utilization of our technology for the treatment of PAD."

"As a long-time user of directional atherectomy and OCT image-guidance, I am extremely enthusiastic about the impact Pantheris LV will have on streamlining the workflow while providing the best-in-class clinical outcomes already produced with Avinger's technologies," noted Dr. Jaafer Golzar, Avinger's Chief Medical Officer. "The enhancements across the entire product portfolio in just this past year, along with captivating new data presented on Pantheris for the treatment of in-stent restenosis and complex below-the-knee lesions, makes a compelling case for any interventionalist to adopt the Lumivascular platform into their treatment algorithm."

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 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.

About Avinger, Inc.Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye® family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.

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Forward-Looking StatementsThis news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our planned launch of Pantheris LV, patient and physician benefits of Pantheris LV, expected growth resulting from the launch and physician adoption of Pantheris LV, and the timing of commercial availability of Pantheris LV. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include the resource requirements related to our products; the timing and outcome of product launch; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2023, as amended, and Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.

Investor Contact:Matt KrepsDarrow Associates Investor Relations(214) [email protected]

Public Relations Contact:Phil PreussChief Marketing OfficerAvinger, Inc.(650) [email protected]

SOURCE: Avinger, Inc.

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