REDWOOD CITY, CA / ACCESSWIRE / February 3, 2021 / Avinger, Inc. (NASDAQ: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 that its Tigereye™ CTO crossing system and Pantheris atherectomy system were featured in a live case transmission on January 29 at the Leipzig Interventional Course (LINC) 2021. LINC is a leading global forum for new methods and technology in the field of vascular medicine held each year in Leipzig, Germany.
Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital in Münster, Germany and a pioneer in the OCT-guided treatment of vascular disease, performed the live endovascular procedure using Tigereye during a session entitled, "CTO-Crossing with New OCT-Image Guided and Steerable Catheter." The patient, a 57-year-old male, presented with severe rest pain in his leg and limited mobility with acute worsening of symptoms over the previous two years. During the case, Dr. Schwindt first safely recanalized the complete blockage in the patient's blood vessel, known as a chronic total occlusion (CTO), with Tigereye. Following the CTO crossing procedure, he used Pantheris to remove the obstructive plaque and restore blood flow to alleviate the patient's symptoms.
Commenting on the case, Dr. Arne Schwindt said, "Tigereye successfully enabled a safe and effective minimally invasive approach to treating this blockage. The device's unique advantages of combining an onboard image-guidance system with a steerable drill tip provide a powerful tool for one of the most challenging patient cohorts. With blood flow now restored to this patient's limbs, he should have a significantly improved quality of life. I want to thank LINC and its organizers for giving me the opportunity to demonstrate this technology at this important platform."
The Tigereye CTO crossing system features high definition, real-time intravascular imaging and a user-controlled deflectable tip designed for steerability within the lumen. Tigereye also includes an enhanced distal tip configuration with rotational speeds up to 1000 RPM designed to penetrate challenging lesions. The Tigereye catheter has a working length of 140 cm and 5 French sheath compatibility to enable treatment of lesions in peripheral vessels both above and below the knee. Tigereye is complementary to Avinger's image-guided atherectomy line of catheters, including the Pantheris Next Generation and Pantheris SV catheters.
Dr. Jaafer Golzar, Avinger's Chief Medical Officer and a highly experienced PAD interventionalist, noted, "Each case we complete with Tigereye continues to support our belief that this new device provides unique and exciting benefits for CTO crossings. The enhanced imaging combined with precise control within the vessel represents a major advance in crossing CTOs. With Tigereye, physicians are demonstrating that they can successfully and more easily cross difficult CTOs and produce positive outcomes for their patients."
In addition to the live case, LINC also featured an abstract submitted by Sehrish Memon, MD, Ramy Sedhom, MD, Sean Janzer, MD, and Jon C. George, MD entitled "Single Center Experience with Optical Coherence Tomography-Guided Directional Atherectomy System for Below-the-Knee Critical Limb Ischemia." A total of twenty-seven patients with critical limb ischemia, an advanced form of peripheral artery disease, were analyzed retrospectively after undergoing plaque debulking with Pantheris SV. For the 21 patients with follow-up data available, 90% (19/21) showed freedom from target lesion revascularization after 6 months, a high rate for these extremely sick patients.
Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray and 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 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 and only image-guided, catheter-based system for the diagnosis and treatment of 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 and Tigereye™ family of chronic total occlusion (CTO) crossing 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 expected benefits of our products, including TIgereye. 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 the 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, 2020, and 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, except as required by law.
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SOURCE: Avinger, Inc.
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