REDWOOD CITY, CA / ACCESSWIRE / August 20, 2024 / 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 full commercial launch of the Pantheris LV image-guided directional atherectomy system. With the initiation of full commercial launch, all current and prospective accounts can now order the Pantheris LV device, a line extension of the first and only image-guided atherectomy device for the treatment of peripheral artery disease (PAD).
Prior to full commercialization, Avinger conducted a limited launch at 16 clinical centers in the United States, with over 20 interventional physicians treating patients with the new device. This initial clinical experience validated the key design enhancements incorporated into Pantheris LV, including higher speed plaque excision for efficient removal of challenging occlusive tissue, and multiple design elements to streamline user-operation. These new features include a proprietary jog mechanism for plaque apposition, an advanced guidewire management system, and design enhancements for improved tissue packing and removal.
Dr. Todd Vogel, Chief of Vascular and Endovascular Surgery at University of Missouri Healthcare, commented on his initial clinical experiences with the device, "The Pantheris LV brings the easy-to-use, single-operator design pioneered with Pantheris SV to the larger vessels such as the superficial femoral and popliteal arteries in which the majority of peripheral interventions occur. Having direct experience with a wide variety of large vessel technologies on the market, I would advocate for Pantheris LV as the interventional tool of choice for most above-the-knee lesions suitable for atherectomy."
Jeff Soinski, Avinger's President and CEO, noted, "We designed Pantheris LV with the specific goal to capture above-the-knee procedure volume share from competitive treatment alternatives, modeled after the success of Pantheris SV for below-the-knee cases. The novel features of this product offer multiple benefits to interventionists, by both expanding its clinical application and simplifying its set up and operation. With refreshed designs across our product portfolio, including our portable Lightbox 3 imaging console, we have built a comprehensive suite of next-generation image-guided devices for the treatment of PAD both above-the-knee and below-the-knee, and for challenging conditions such as chronic total occlusions and in-stent restenosis."
Avinger's proprietary 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 Avinger's unique 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 image-guided, catheter-based system for the diagnosis and treatment of patients with vascular disease in the peripheral and coronary arteries. 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 for the treatment of peripheral artery disease (PAD), estimated to affect more than 200 million people worldwide. Avinger is developing its first product application for the treatment of coronary artery disease (CAD), an image-guided system for CTO-crossing in the coronary arteries, which provides the opportunity to redefine a large and underserved market. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
This 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 the anticipatedpatient and physician benefits of our products, including 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 studies; 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 20, 2024, as amended, and Quarterly Reports 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.
