REDWOOD CITY, CA / ACCESSWIRE / April 21, 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 the publication of two clinical studies in peer-reviewed journals, further supporting the clinical benefits of its therapeutic devices. The studies were based on separate clinical case series conducted by physicians at the Division of Cardiovascular Disease and Endovascular Medicine at the Einstein Medical Center in Philadelphia, Pennsylvania.
"These two studies demonstrate the utility of Avinger's OCT-guided approach for the treatment of PAD in complex and challenging cases and patient populations," commented Dr. Jon George, an interventional cardiologist and endovascular specialist at the University of Pennsylvania Health System and an author of both publications. "Due to the small size of the vessels being treated below-the-knee (BTK), the limited treatment options available to many of these patients, and our early clinical experience, I believe that Pantheris SV is proving to be a valuable new tool to safely and effectively treat this challenging form of disease, especially in critical limb ischemia (CLI) patients. We are excited about the early results from this study and look forward to continuing to contribute to the body of knowledge in support of this innovative new approach to the treatment of vascular disease."
Dr. George continued, "Patients suffering from chronic kidney disease (CKD), a common co-morbidity within the PAD patient population, often have limited endovascular treatment options available to them due to the potential for contrast-induced nephropathy, a potentially severe complication of overexposure to contrast dye used in fluoroscopic-guided interventions. By using CO2 angiography, which limits the need for contrast-dye, and Avinger's OCT-guided therapeutic catheters, which require no contrast dye and generate no X-ray radiation, we were able to significantly reduce the need for contrast agents, total fluoroscopy time and radiation exposure for these patients suffering from PAD and CKD. We are excited about the potential for making more patients, who previously would have been referred for bypass or other more invasive procedures, eligible for less-invasive, highly effective endovascular treatment, which would provide an extremely valuable clinical benefit to these patients."
Dr. Jaafer Golzar, an interventional cardiologist and Avinger's Chief Medical Officer, stated, "These two recent clinical publications further highlight the safety and efficacy of Avinger's PAD therapies, joining a body of work encompassing more than twenty clinical publications in peer-reviewed journals detailing the use of our Lumivascular technologies. We appreciate the pioneering efforts of physicians, like Dr. George and the other contributors to these studies, in documenting the positive clinical outcomes they are achieving with our devices in challenging patient populations. We learn from their experiences and they are helping to pave the way for meaningful clinical advances in the treatment of vascular disease."
The first study, published in the March 2021 edition of the Journal of Critical Limb Ischemia and entitled "Single-Center Experience with Optical Coherence Tomography-Guided Directional Atherectomy System for Below-the-Knee Critical Limb Ischemia," highlights the safety and efficacy of Avinger's innovative Pantheris SV catheter in the treatment of below-the-knee (BTK) peripheral artery disease. PAD in the vessels below knee can often present as the most severe form of the disease, known as critical limb ischemia (CLI), and typically require a revascularization procedure to avoid serious consequences such as an amputation.
The study followed 27 patients treated with Pantheris SV, Avinger's OCT-guided atherectomy platform designed for below-the-knee vessels. Post treatment with Pantheris SV, observed stenosis across the patient group declined from 85% to 21.5%, an improvement of 63.5%. The study concluded that the use of Pantheris SV in BTK treatment resulted in appreciably low incidence of target lesion revascularization (TLR), an indication of restenosis, at 6 months post procedure, a key finding in the results. Freedom from TLR was 90.5%, a very positive longer-term outcome for these patients with severe PAD, especially given the limitations of other minimally invasive approaches for the treatment of critical limb ischemia as highlighted in the discussion section of the publication.
This study represents the first observational assessment of Pantheris SV for BTK treatment. To further validate these early findings, Avinger is currently enrolling the IMAGE-BTK clinical study, targeting enrollment of 60 patients, with patient follow-up at 30-days, 6-months, and 1-year post-treatment.
The second study, titled "Safety and outcomes of combined carbon dioxide angiography and OCT-guided femoro-popliteal chronic total occlusion crossing and directional atherectomy in patients with chronic kidney disease" was published in the journal Vascular. The investigators applied the use of carbon dioxide angiography in combination with Avinger's OCT-guided therapies to improve the interventional outcomes for PAD patients suffering from chronic kidney disease (CKD). This subset of PAD patients has limited treatment options due to the potential for contrast-induced nephropathy (CIN), a potential complication of fluoroscopic-guided interventions requiring contrast dye. CIN is known to be consistent with longer hospital stays, increased morbidity and mortality, and higher financial cost and common in CKD patients due to dye sensitivity.
The study examined outcomes for 11 patients and 18 total lesions treated, with the entire cohort suffering from baseline chronic kidney disease. The study concluded that "carbon dioxide angiography with the addition of optical coherence tomography imaging for chronic total occlusion crossing and/or optical coherence tomography-guided directional atherectomy reduced the need for contrast agents, total fluoroscopy time, and radiation exposure in patients with peripheral artery disease and baseline chronic kidney disease." Importantly, the interventions had durable mid to long-term results with very low need for target lesion revascularization over a six-month time period.
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) 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 our future performance, patient benefits of our products, including Pantheris SV, and the timing and results of clinical studies. 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 Pantheris, TIGEREYE and our Lightbox imaging console and related studies; the outcome of clinical trial and study 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 11, 2021. 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.
Chief Financial Officer
Darrow Associates Investor Relations
SOURCE: Avinger, Inc.
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