REDWOOD CITY, Calif., Dec. 13, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (Nasdaq: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that physicians in 59 sites globally have successfully treated more than 500 patients with the next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD).
The next-generation Pantheris was launched on a limited basis in the U.S. following receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in late May 2018 and features a number of improvements intended to augment the performance and reliability of the product. Importantly, clinical results have remained consistently positive across a variety of lesions and consistent with early outcomes reported previously. Initial market uptake, acute clinical outcomes, and physician feedback validate that the design enhancements have driven adoption of the next generation device, as evidenced by a 38% year-over-year increase in Pantheris sales in the third quarter of 2018, its first full quarter following launch.
Dr. Gary Fishbein, an interventional cardiologist at Miami Valley Hospital in Dayton, Ohio and an experienced user of next-generation Pantheris, commented, “The new product features have significantly improved cutting efficiency, precision, and ease of use of the device, broadening its clinical applicability within my practice. The onboard image guidance system combined with a directional plaque excision mechanism allows me to maximize luminal gain while avoiding vascular injury during an intervention, which I believe produces better long-term results for my patients.”
“The repeated positive outcomes across more than 500 patients with physicians in multiple sites reinforces the initial clinical experiences observed during our limited launch of the product,” said Jeff Soinski, Avinger’s President and CEO. “We are pleased to reach this milestone after launching just 6 months ago and view the next-generation Pantheris as a platform for growth in catheter revenue in 2019, both from continued expansion in current accounts and launching the product with potential new customers.”
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, 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 Avinger’s the benefits of the next-generation Pantheris, reduction in radiation exposure, data supporting the use of Pantheris, and increased clinical applicability of Pantheris technology. 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 November 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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