OCT Imaging with Pantheris Superior or Equivalent to IVUS on all Parameters
REDWOOD CITY, CA / ACCESSWIRE / February 25, 2020 / 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 that the results of its SCAN clinical study have been published in the peer-reviewed journal BMC Medical Imaging. SCAN is a prospective, non-inferiority, post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. Study results showed that OCT imaging with Avinger's Pantheris system demonstrated statistical superiority or equivalence to IVUS on all parameters evaluated. While OCT has been documented to have approximately 10 times greater resolution than conventional IVUS, SCAN is the first clinical study comparing diagnostic imaging with IVUS and OCT in peripheral vessels of patients in the United States.
Dr. Edward Pavillard, a vascular surgeon at Pottstown Hospital Tower Health in Pottstown, Pennsylvania, and Dr. Luke Sewall, an interventional radiologist and president of Vascular and Interventional Professionals in Hinsdale, Illinois served as the principal investigators of the study. As part of the protocol, 120 OCT and IVUS matched images (240 images in total) were captured at identical positions within vessel segments of multiple patients at two clinical centers. Three independent radiologists then reviewed the matched images and ranked them in terms of image quality and ability to display vessel morphology, disease, and important intravascular structures. Vessel measurement capabilities were also compared between the two imaging modalities.
The data analysis from the reviewer rankings of the 240 images indicated that OCT imaging with Pantheris was significantly better than IVUS in visualizing plaque, calcification, and stent struts. OCT imaging was ranked to be statistically the same as IVUS in visualizing the vessel wall components and treatment zones within the artery. Vessel measurement and interference of artifacts with imaging quality were also seen to be statistically equivalent between the two imaging modalities.
Dr. Pavillard commented, "We would like to thank our colleagues at BMC Medical Imaging for publishing these important data in an independent, peer-reviewed format. The results of this study further validate how intravascular image-guidance allows the physician to assess the burden and location of plaque within a vessel, understand plaque composition, and gain further insights on the patient's condition. This information attained from within the vessel, especially in real-time with an interventional technology such as Pantheris, can produce safer and more effective results for our patients than if we rely solely on traditional X-ray fluoroscopic imaging, which only provides an overhead view of the artery. The added benefit of increased accuracy in vessel diameter sizing also helps appropriately size adjunctive therapy such as stents and balloons, which has shown to improve patient outcomes."
Jeff Soinski, Avinger's president and CEO, commented, "We appreciate the pioneering work of Drs. Pavillard and Sewall in adding to the clinical body of evidence supporting the value of intravascular imaging for the treatment of patients with PAD. The FDA has cleared separate 510(k) submissions for both diagnostic and therapeutic treatment indications for our OCT image-guided Pantheris atherectomy and Ocelot CTO-crossing systems. Reimbursement codes applicable to therapeutic peripheral interventions with our image-guided catheters already exist. We intend to use the results of the SCAN study to support a broader 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."
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 proprietary Lightbox console. Physicians performing atherectomy or crossing CTOs 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 the benefits of Pantheris and Ocelot, reduction in radiation exposure, data supporting the use of Pantheris and Ocelot, the Company's efforts to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries, 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 and Ocelot; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2019 and in our other filings with the SEC, including, without limitation, our reports on Form 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, speak only as of the date hereof and reflect management's current estimates, projections, expectations and beliefs. Avinger disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avinger's expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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SOURCE: Avinger, Inc.