REDWOOD CITY, Calif., Jan. 28, 2019 (GLOBE NEWSWIRE) -- Avinger, Inc. (AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that its Pantheris® SV (Small Vessel) image-guided atherectomy system was featured in a live case transmission at Leipzig Interventional Course (LINC) 2019, a leading global forum for new methods and technology in the field of vascular medicine held annually in Leipzig, Germany.
Pantheris SV is a product line extension of Avinger’s Lumivascular image-guided atherectomy system. Designed with a lower profile and longer length, Pantheris SV is intended to expand the addressable market for Pantheris, by allowing physicians to treat lesions in smaller vessels 2 to 4 millimeters in diameter. Pantheris SV received CE Marking in October 2018 and is available in limited supply for commercial sale in the European Union (EU). Pantheris SV is not available commercially in the United States at this time.
Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital in Münster, Germany and a pioneer in the Lumivascular treatment of vascular disease, performed the live endovascular procedure using Pantheris SV during a session entitled, “Disruptive Treatment Approaches and Pioneering Techniques for Patients with Vascular Disease.” The patient presented with critical limb ischemia (CLI), a severe stage of PAD that requires immediate attention, stemming from an occlusion of the popliteal artery and extensive stenoses of several of the smaller vessels below the knee. Dr. Schwindt safely treated the most vital sections of the diseased arteries, including a complete blockage of the popliteal to restore blood flow and prevent the acute threat of amputation. The debulking treatment was followed by the use of drug-coated balloons. Based upon the resulting restoration of blood flow, there was no need to place a vascular stent.
Commenting on the case, Dr. Arne Schwindt said, “Due to the location of the lesions in small caliber vessels and multiple previous procedures, our treatment strategy focused on revascularizing the patient’s arteries without the need for permanent implants. Treating the popliteal and smaller vessels can present significant challenges, and a high safety profile of any interventional device is of paramount importance in this area of the vasculature due to the potential severity of complications. Pantheris SV, which combines onboard image-guidance with a directional plaque excision mechanism, provides an unparalleled degree of precision and safety needed for this anatomical area. With this patient at high risk of requiring an amputation if unsuccessful, I am especially pleased with the outcome. I want to thank LINC and its organizers for giving me the opportunity to demonstrate this technology at this important platform, as I believe it represents a significant advance in treating small vessel disease.”
Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly experienced interventionalist in caring for CLI patients with small vessel disease, noted, “As an advocate for amputation avoidance and the minimally invasive treatment of CLI patients, I have eagerly awaited a new endovascular tool that can deliver safer and more effective outcomes for this high-risk segment of PAD sufferers. 25% to 33% of CLI patients undergo a major amputation as the primary treatment of CLI, and 60%-71% receive no revascularization procedure due to numerous contributing factors. We believe Pantheris SV could represent an important step forward in the treatment of these patients.”
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 the benefits of Pantheris SV, 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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