REDWOOD CITY, CA / ACCESSWIRE / June 20, 2023 / 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 vascular disease, today announced two podium presentations featuring the company's Lumivascular technology at the Leipzig Interventional Course (LINC) 2023, 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 OCT-guided atherectomy system and the results of the INSIGHT trial in his presentation, "Gender Differences in Treatment of ISR Lesions with the Pantheris Atherectomy Catheter." The INSIGHT trial was designed to evaluate the safety and effectiveness of Avinger's Pantheris image-guided atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries.
- Dr. Michael Lichtenberg, Chief Medical Officer and Director of the Angiology Department and Vascular Center at Klinikum Arnsberg, presented interim data from the post-market IMAGE-BTK trial designed to evaluate the safety and effectiveness of Avinger's Pantheris SV OCT-guided atherectomy system in treating below-the-knee lesions. His presentation was entitled, "Treatment of Stenotic Lesions Below-the-Knee with an OCT-Guided Atherectomy Catheter."
Dr. Schwindt commented on the INSIGHT trial and his findings, "The results from the INSIGHT trial validate the benefits of Pantheris for patients suffering from the effects of in-stent restenosis. In the first analysis of its kind examining gender differences in the presentation and recurrence of ISR, we found variability in lesion length and percent stenosis between males and females, and slightly lower freedom from target lesion revascularization (TLR) in females. Across the entire population of patients treated with Pantheris as part of this trial, 93% exhibited freedom from TLR at 6 months and 89% freedom from TLR at 12 months, representing best-in-class outcomes for the treatment of in-stent restenosis. At St. Franziskus Hospital, we have shown similarly excellent results using Pantheris for treating lesions not occurring within stents, achieving 100% freedom from TLR at 12 months and 93% patency amongst a significant patient cohort. The onboard image-guidance paired with a directional excision mechanism in Pantheris allows the operator to avoid interactions with vascular structures or embedded implants while generating optimal luminal gain, providing patients more durable outcomes."
Regarding his presentation, Dr. Lichtenberg noted, "Pantheris SV shows enormous promise for the treatment of PAD in challenging below-the-knee anatomy, backed by real-world data in patients in Rutherford Class 3 through 6. We have seen tremendous outcomes for patients at 6 and 12-month follow-up at this point in the IMAGE-BTK study, with 96% freedom from TLR and 93% patency at 12-months, and 100% freedom from major adverse events across enrollees. As compared to restenosis rates as high as 70% using balloon angioplasty, these type of results support OCT-guided directional atherectomy as an excellent option to address vascular disease in the arteries below-the-knee."
Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians 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 the results of our IMAGE-BTK and INSIGHT studies, and anticipated patient and physician benefits of our products, including Pantheris and Pantheris SV. These risks and uncertainties, many of which are beyond our control, include the resource requirements related to our products; the timing and outcome of studies; 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 16, 2023, as amended, and Quarterly Report 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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