Post-Market Study Compares Pantheris OCT Imaging with IVUS for Diagnostic Imaging in Peripheral Arteries
REDWOOD CITY, Calif., Aug. 23, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that it has completed enrollment in the SCAN clinical study, a post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries.
Avinger’s proprietary Lumivascular technology utilizes OCT to provide real-time vascular imaging for the diagnosis and treatment of peripheral artery disease. OCT is a light-based, high-definition imaging modality, which generates no X-ray radiation, and has a resolution approximately ten times greater than IVUS. The U.S. Food and Drug Administration (FDA) has cleared both diagnostic and therapeutic treatment indications for use for Avinger’s Pantheris (atherectomy) and Ocelot (CTO-crossing) image-guided catheters. While reimbursement codes applicable to therapeutic peripheral interventions with the Company’s image-guided catheters already exist, the results of the SCAN study are intended to support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries similar to the reimbursement currently provided for the use of IVUS as a diagnostic tool in this setting.
Enrollment in the SCAN study was initiated at two centers in the United States in June 2018 with the goal of acquiring at least 115 matched images generated by OCT and IVUS from up to 20 subjects diagnosed with PAD. The study exceeded this goal with greater than 115 OCT and IVUS matched images captured at identical positions within vessel segments from 14 subjects. These images have been submitted to three independent radiologists who will review the matched images and rank them for clarity to identify vessel morphology (e.g., the components of vessel wall layers, bifurcation) abnormal physiology (e.g., plaque, dissection, thrombus, calcium), and artifacts. Vessel measurement will also be compared between the two imaging modalities. Once final study results are available, it is anticipated that they will be publicly-released by Avinger and submitted for publication by the physician investigators in the study, Dr. Edward Pavillard, a vascular surgeon at PA Vascular Institute in King of Prussia, Pennsylvania, and Dr. Luke Sewall, an interventional radiologist and president of Vascular and Interventional Professionals in Hinsdale, Illinois.
“The SCAN study complements and expands the body of clinical data highlighting the importance of intravascular imaging for the diagnosis and treatment of peripheral arterial disease,” said Dr. Jaafer Golzar, Avinger’s chief medical officer. “Drs. Pavillard and Sewall have done a tremendous job enrolling in this important trial. Clinical experience has shown us that OCT is equivalent and in certain situations superior to IVUS for intravascular imaging. Once final results are available from SCAN, we hope to have a robust clinical study supporting this concept.”
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). 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, CA. 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 process for gaining additional reimbursement for Avinger’s products and the results of the SCAN 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; 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-Q filed with the Securities and Exchange Commission on August 13, 2018. 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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