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Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial
Wednesday, July 10, 2019 9:40 AM
Positive early outcomes in complex in-stent restenosis cases with few therapeutic options
REDWOOD CITY, CA / ACCESSWIRE / July 10, 2019 / Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the 50th patient enrolled in its INSIGHT clinical trial. The INSIGHT trial is a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris® Lumivascular atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries.
Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly experienced interventionalist, noted, “We are pleased to have the first 50 cases completed as part of our INSIGHT IDE study. Early results are encouraging, and we anticipate that one of the study’s physician investigators will present an interim analysis of initial patient outcomes at an upcoming clinical conference. We believe a specific indication for the treatment of ISR, which currently has very limited treatment options, will be an important label expansion for Pantheris. Once the IDE study is completed, we plan on filing a 510(k) application with the FDA to pursue this claim.”
Up to 140 patients will be enrolled in the INSIGHT trial at up to 20 U.S. and international centers. Dr. Sean Janzer, of Einstein Medical Center, and Dr. Glen Schwartzberg, of Baton Rouge General Medical Center, serve as co-principal investigators of the study. In-stent restenosis occurs when a blocked artery previously treated with a stent becomes narrowed again, reducing blood flow. Physicians often face challenges when treating in-stent restenosis both in terms of safety and efficacy. From a safety standpoint, limitations in imaging techniques, such as X-ray fluoroscopy, and the inability to control the directionality of certain treatment modalities creates the concern of potentially impacting the integrity of the stent during the intervention. In terms of efficacy, current therapies for in-stent restenosis, such as balloon angioplasty, have high rates of recurrent renarrowing within stents.
Dr. Schwartzberg commented, “In-stent restenosis represents a difficult clinical challenge with limited minimally invasive treatment options that provide durable long-term results. Real-time intravascular imaging combined simultaneously with a targeted mechanism of action in the Pantheris system enables observation of the vessel lumen and stent architecture during an intervention, which I believe will enhance safety and outcomes in these high-risk patients. This addresses the critical problem of either over or under treatment and the subsequent complications associated with these events while treating arterial occlusive disease within a stent.”
“Patients experiencing in-stent restenosis may incur the risk of additional harm when other treatment modalities fail to provide the precise imaging and directional control critical to treating the restenosed stents and may even require a referral to a bypass surgery or even amputation,” said Dr. Janzer. “The Pantheris Lumivascular atherectomy system provides interventionalists with real-time intravascular imaging and enhanced control to more precisely direct plaque excision while avoiding the stent struts, potentially leading to better patient outcomes in these challenging cases.”
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 upcoming expected milestones in its business. 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 May 8, 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.
Chief Financial Officer
Darrow Associates Investor Relations
SOURCE: Avinger, Inc.