Avinger Announces 510(k) Filing of Pantheris LV
Avinger, Inc. (NASDAQ:AVGR) announced the submission of a new 510(k) application for Pantheris LV, a next-generation image-guided atherectomy system designed for larger vessels affected by Peripheral Artery Disease (PAD). This system aims to offer enhanced plaque excision speed and user operation. Avinger expects to launch Pantheris LV in the U.S. by the second half of 2023, pending FDA clearance. Additionally, the technology integrates optical coherence tomography to provide real-time imaging, improving procedural accuracy and reducing reliance on X-ray imaging.
- Submission of 510(k) application for Pantheris LV may enhance market presence.
- Expected U.S. launch in the second half of 2023 could drive sales.
- Innovative technology features, like optical coherence tomography, may improve procedural outcomes.
- Dependence on FDA clearance introduces uncertainty in launch timeline.
- Potential risks and uncertainties inherent in product adoption and clinical trial timings.
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.
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 Statements
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 patient and physician benefits of our products, physician adoption of our products, and expected timing of launching Pantheris LV into U.S. distribution. 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 our dependency on a limited number of products; the resource requirements related to our products; the timing and outcome of clinical trial results; 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 22, 2022 and our Quarterly Report on Form 10-Q filed on November 9, 2022. 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 Kreps
Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com
Public Relations Contact:
Phil Preuss
Chief Marketing Officer
Avinger, Inc.
(650) 241-7942
pr@avinger.com
SOURCE: Avinger, Inc.
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