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Avinger Announces 510(k) Filing of Pantheris Small Vessel Device
Anticipated to Expand Addressable Market for Pantheris Family
REDWOOD CITY, Calif., Aug. 30, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the Company submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) for the Pantheris SV (Small Vessel) Lumivascular atherectomy system.
Pantheris SV is a line extension of the Pantheris family of catheters, the first and only image-guided atherectomy devices for the treatment of PAD. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller diameter vessels and more distal regions of the vasculature. Pantheris SV incorporates key improvements introduced to the platform with the clearance of the next generation Pantheris system in May 2018, including a stiffer shaft for increased pushability, a refined OCT imaging system, a more robust nosecone, and an enhanced cutter design.
“Effective tools to address lesions in smaller vessels represent an important unmet clinical need in the treatment paradigm for PAD,” said Dr. Jaafer Golzar, Avinger’s Chief Medical Officer. “There is a lack of long-term durability noted with other treatment options in this area of the vasculature. However, the concept of pairing onboard image-guidance with a directional atherectomy system could provide a number of significant clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and a potential enhancement in the uptake of anti-restenotic drug therapy,” Dr. Golzar continued.
Jeff Soinski, Avinger’s President and CEO commented, “This submission represents an important milestone in positioning the company for growth in 2019. We are hopeful that this filing will lead to U.S. market availability of Pantheris SV by early 2019, which we believe would allow us to address a significantly larger portion of the estimated $500 million atherectomy market. We are excited to get this next generation small vessel device into the hands of Lumivascular physicians.”
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as 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, thanks to the real-time OCT images generated from inside the artery, 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-ever image-guided, catheter-based system that diagnoses and treats 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 imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, CA. 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 launch of new products, the timeline associated therewith and the benefits of Pantheris SV. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. 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; our ability to demonstrate the benefits of our Lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results; potential exposure to third-party product liability, intellectual property and other litigation; lack of long-term data demonstrating the safety and efficacy of our Lumivascular platform products; experiences of high-volume users of our products may lead to better patient outcomes than those of physicians that are less proficient; reliance on third-party vendors; dependency on physician adoption; reliance on key personnel; and requirements to obtain regulatory approval to commercialize our products; as well as the other risks described in the section entitled “Risk Factors” and elsewhere in our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 13, 2018. 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.
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