REDWOOD CITY, CA / ACCESSWIRE / June 15, 2022 / 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 two podium presentations and a live case transmission featuring the company's Lumivascular technology at the Leipzig Interventional Course (LINC) 2022, which took place June 6 through June 9. LINC is a leading global forum for new methods and technology in the field of vascular medicine held each year in Leipzig, Germany.
Key opinion leaders in the fields of interventional cardiology and endovascular interventions highlighted Avinger's Lumivascular technology in the following sessions:
- Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital in Münster, Germany and a pioneer in the OCT-guided treatment of vascular disease, featured Avinger's Pantheris SV (small vessel) OCT-guided atherectomy system and his single center experience with the device in his presentation, "OCT-guided Atherectomy for BTK-Disease, Clinical Outcomes in a Prospective and Analyzed Patient Cohort."
- Dr. Michael Lichtenberg, head of the department of angiology at Klinikum Arnsberg and past president of the German Society for Angiology, presented data from the INSIGHT trial designed to evaluate the safety and effectiveness of Avinger's Pantheris OCT-guided atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries. His presentation was entitled, "Treatment of ISR Lesions with the Pantheris Atherectomy Catheter."
- Dr. Arne Schwindt and Dr. Safa Al-Qudah also performed a live endovascular procedure from St. Franziskus Hospital, featuring Pantheris treatment of a 65-year-old female with restenosis of a previously placed nitinol stent in the superficial femoral artery. The case illustrated the benefits of onboard image-guidance for treating the recurrent blockage without any negative interactions with stent struts and resulted in an excellent outcome for the patient.
Dr. Schwindt commented on his single-center experience with Pantheris SV, "Onboard image-guidance allows for safer and more effective outcomes across most patient cohorts, and especially for the treatment of below-the-knee lesions and in-stent restenosis. With the suboptimal limb salvage and primary patency rates shown by angioplasty, I have integrated Pantheris SV into my treatment algorithm for below-the-knee procedures with excellent results, as shown by the dramatic 89% improvement in Rutherford class in my patient cohort and 100% amputation free survival rate over an average 23-month follow-up time. I am excited to participate in the IMAGE-BTK study to further validate Pantheris SV as a new standard for below-the-knee lesions. I want to thank LINC and its organizers for giving me the opportunity to demonstrate this technology at this important platform."
Regarding his presentation, Dr. Lichtenberg noted, "The INSIGHT trial demonstrates that Pantheris should be a frontline therapy for patients suffering from in-stent restenosis. The 93% freedom from target lesion revascularization (FF TLR) at 6-months and 89% FF TLR at 12 months shown in this study represent best-in-class outcomes in the ISR space. The Pantheris technology allowed for substantial luminal gain of 82% on average and none of the patients underwent an amputation. Importantly, these patients experienced a significant improvement in Rutherford class and ankle-brachial index measures across the length of the study. With limited options available for the treatment of ISR, Pantheris represents an exciting new option for this significantly sized cohort of PAD patients."
Jeff Soinski, Avinger's President and CEO, commented, "The data and live case presented by Dr. Lichtenberg and Dr. Schwindt at LINC further support the strong clinical foundation we are creating for the safe and effective treatment of vascular disease with OCT-guided technology, especially in the areas of in-stent restenosis and below-the-knee intervention. We are excited that Dr. Lichtenberg and Dr. Schwindt will be joining our IMAGE-BTK study for Pantheris SV, which has already shown very promising results at 6 and 12 months post procedure for the initial cohort of patients. The support shown by these key opinion leaders helps us build momentum as we approach the market with new, impactful data and the speed and flexibility provided by our new portable Lightbox 3 imaging console."
Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians, for the first time ever, to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence tomography, or OCT. During the procedure, high-resolution intravascular OCT images are displayed on Avinger's Lightbox console in real-time to guide therapy. Physicians performing therapeutic procedures with other devices must rely solely on X-ray images 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 to deliver safe and effective outcomes, 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 series of imaging consoles, the Ocelot and Tigereye™ 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 patient and physician benefits of our products, and the effects of certain physicians joining our IMAGE-BTK study. 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; the resource requirements related to our products; the timing and outcome of clinical trial results; 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 22, 2022 and our Quarterly Report on Form 10-Q filed on May 10, 2022. 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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