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Includes New Sites in Florida, Georgia and Arizona PAD Markets
REDWOOD CITY, CA / ACCESSWIRE / October 9, 2019 / Avinger, Inc. (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 launch of seven new Lumivascular centers during the third quarter, including sites in the high-volume PAD markets of Florida, Georgia and Arizona. This growth in new accounts is the result of continued expansion of Avinger's sales team and strong market demand for the Company's Pantheris and Pantheris SV image-guided atherectomy products.
"We are excited to report the launch of seven new clinical centers using Avinger's best-in-class Lumivascular platform during the third quarter, as we continue to expand our geographic reach in the U.S. and bring highly differentiated new products to market," said Jeff Soinski, Avinger's President and CEO. "Clinical outcomes consistently show that our unique combination of real-time intravascular imaging with directional atherectomy allows physicians to provide precise and highly effective therapy for their patients with PAD. These outcomes are driving market excitement across our entire product platform, including our new Pantheris SV device."
"Pantheris SV offers a high quality intravascular atherectomy tool for small vessel PAD, an underserved indication," continued Soinski. "This unique and compelling therapeutic device commenced its full commercial launch in September and garnered orders from more than 25 sites prior to the end of the third quarter. We anticipate further growth across our entire Pantheris product line in the fourth quarter, driven by increased utilization of our Pantheris next generation atherectomy device and further rollout of Pantheris SV to additional sites in our user network."
Peripheral artery disease (PAD) is a common circulatory problem in which arteries are narrowed due to the buildup of fatty deposits, known as plaque. These blockages, which can be partial or complete, reduce blood flow to the limbs, most commonly in the legs and feet. Because the limbs do not receive enough blood flow to keep up with demand, patients with PAD can suffer a number of symptoms, most notably leg pain when walking. Additional symptoms may include leg numbness or weakness, coldness in the lower leg or foot, sores on the toes, feet or legs that won't heal, or a change in the color of the legs, among other presentations.
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Avinger's Lumivascular technology allows physicians, for the first time ever, to see 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 images 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, due to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
Avinger's newest product, Pantheris SV, expands Avinger's portfolio of image-guided atherectomy devices for the treatment of PAD in smaller vessels, an indication with limited treatment options. This expansion is expected to increase the number of addressable procedures for the Company's Lumivascular technology. Pantheris SV features a longer 140 cm catheter length and a smaller six French (6F) profile to allow physicians to target more distal regions of the vasculature in smaller diameter vessels, including those below-the-knee. Introduced to the U.S. market in the third quarter of 2019, physicians have used Pantheris SV to successfully treat lesions within a variety of treatment scenarios in all of the major arteries between the knee and ankle. Treating physicians have provided positive feedback on the device's ease of use, image clarity, cutting efficiency, and user control.
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 our future performance, expectations regarding the number of active Lumivascular accounts, the increase of our available atherectomy market, the impact of Pantheris SV on our addressable market, patient outcomes, and expansion of international distribution 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. 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; and reliance on key personnel; 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 6, 2019, as well as in our 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.
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SOURCE: Avinger, Inc.
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