Seven patients successfully treated using next generation image-guided atherectomy device for treatment of peripheral artery disease
REDWOOD CITY, Calif., Jan. 03, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in Münster, Germany, has successfully treated the first seven patients with the next generation Pantheris Lumivascular atherectomy system. Dr. Schwindt, an experienced operator of Lumivascular technology, used the next generation Pantheris to treat seven separate patients with a variety of lesion types, including in-stent restenosis (ISR), a calcified lesion, and a chronic total occlusion, in arteries above and below the knee.
The next generation Pantheris design includes a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a more robust nose cone with the option for more tissue storage capacity, and an enhanced cutter design. This device is available in limited supply for commercial sale in the EU; it is not available commercially in the United States at this time.
In each of the seven cases, Pantheris performed as intended, and Dr. Schwindt made note of the design features that enabled significant performance improvements as compared to previous versions of the device, including better directional control of the cutter blade for more precise atherectomy. Dr. Schwindt also provided feedback about the increased maneuverability of the system, greater tissue capture versus the similarly sized previous version of Pantheris, increased efficiency and ease of cleaning the device between insertions, and high quality imaging in a variety of vessel diameters.
In commenting on his initial cases, which included a patient with a total occlusion of a stent and multiple below-the-knee lesions, Dr. Schwindt noted, “Next generation Pantheris with real-time image guidance enabled me to see the stent struts and precisely target and remove substantial amounts of tissue that had grown into the stent. In two patients the disease extended below the knee. Image-guided atherectomy with the next generation Pantheris made it possible to precisely target and remove atherosclerotic plaque in this region while conserving the deep wall components and thus reducing the risk of perforations in these small vessels. The angiographic outcome was excellent.”
“We are thrilled that Dr. Schwindt was the first in the world to use the next generation of Pantheris, especially given the excellent outcomes for patients in this initial experience with the device,” said Jeff Soinski, Avinger’s president and CEO. “These cases helped to validate the enhancements we have made to Pantheris, both in terms of performance and reliability. We believe the initial results generated by Dr. Schwindt with the device represent an important step both for Avinger and for the evolution of treatment for patients with PAD.”
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). 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 PantherisÒ 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 the performance of our next-generation device and its potential implications and improvements over prior versions of the device. 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 Form 10-Q filing made with the Securities and Exchange Commission on November 14, 2017. 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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