93% Primary Patency Rate and 100% Freedom from Target Lesion Revascularization at 12 Months
REDWOOD CITY, CA / ACCESSWIRE / April 15, 2019 / Avinger, Inc. (NASDAQ: AVGR), a leading developer of image-guided, catheter-based systems for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced the publication of very promising clinical outcomes data from a study evaluating the performance of the Pantheris® Lumivascular atherectomy system combined with antirestenotic therapy in the treatment of PAD. This retrospective single-center, single-arm study has been published in the April 2019 issue of the peer-reviewed Journal of Cardiovascular Surgery under the title "Optical Coherence Tomography Guided Directional Atherectomy with Antirestenotic Therapy for Femoropopliteal Arterial Disease."
The study analyzed the clinical outcomes of 33 patients (37 lesions) with symptomatic peripheral arterial disease treated by OCT-guided atherectomy with Pantheris prior to application of a drug-coated balloon. Follow-up examinations were scheduled at 6 and 12 months following the initial procedure. The primary outcome measure of the study was primary patency of the treated vessels as measured by duplex ultrasound at follow-up. The study reported an overall primary patency rate of 93% at 12 months. Freedom from target lesion revascularization (TLR), an indication of restenosis, was 100% with no patients showing TLR at 12 months. The procedure had a technical success rate of 95%. The analysis also demonstrated that Pantheris generated sufficient luminal gain, and low rates of bailout stenting and perioperative adverse events. Complete study results are available in the published article.
Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital in Muenster, Germany and principal operator in these cases, commented, "I believe that onboard image-guidance while performing atherectomy provides advantages in both safety and efficacy for many types of lesions. In this study, we analyzed the outcomes for patients treated with Pantheris prior to the application of antirestenotic therapy. These very promising 12-month results are encouraging as we continue to realize the unique clinical benefits of this technology."
Dr. Jaafer Golzar, Avinger's Chief Medical Officer, and a highly experienced interventionalist noted, "I firmly believe that safely debulking diseased tissue while minimizing injury to the native vessel can produce great standalone results but also enhance adjunctive therapies. Our mission is to empower physicians with real-time information both during and after the procedure, so they can precisely target disease and decide how best to apply adjunctive therapy. These data illustrate the very positive outcomes achievable when using Pantheris image-guided atherectomy to safely prepare the vessel prior to the application of adjunctive therapy."
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 Avinger's the benefits of Pantheris, 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-K filed with the Securities and Exchange Commission on March 6, 2019. 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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SOURCE: Avinger, Inc.