Avinger Enrolls First Patient in IMAGE-BTK Clinical Study Evaluating Safety and Efficacy Endpoints for Pantheris SV
Post-Market Study Intended to Support Commercial Expansion of Small Vessel Image-Guided Atherectomy Device
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 initiation of the IMAGE-BTK clinical study for its Pantheris SV image-guided atherectomy system. IMAGE-BTK is a post-market trial designed to evaluate safety and efficacy endpoints for Pantheris SV in the treatment of peripheral artery lesions below-the-knee (BTK). Dr. Thomas Davis, an interventional cardiologist at Eastlake Cardiovascular, P.C. in Saint Claire Shores, Michigan, enrolled the first patient in IMAGE-BTK and will serve as the principal investigator of the study.
After enrolling the first patient in IMAGE-BTK, Dr. Davis commented, "The breadth of data gathered from this study will be an important validation of OCT-guided directional atherectomy for the treatment of peripheral artery disease in the small vessels below-the-knee. As one of the first users of Pantheris SV, I have seen impressive acute results from a safety and technical success standpoint with no major adverse events and excellent luminal gain; two factors that should contribute to better long-term outcomes for these patients. I am excited to initiate this important study to gather more formal data across several sites and to corroborate my own observations about the safety and efficacy of Pantheris SV for below-the-knee interventions."
Pantheris SV was launched into the U.S. market in the third quarter of 2019 following the receipt of 510(k) pre-marketing clearance by the United States Food and Drug Administration (FDA). The IMAGE-BTK study is intended to support further commercial expansion of Pantheris SV through the development of controlled clinical data evaluating the safety and efficacy of the device in a real-world clinical setting.
"IMAGE-BTK represents an important component of our launch strategy for Pantheris SV," noted Jeff Soinski, Avinger's president and CEO. "We believe this trial will provide compelling clinical evidence supporting the use of Pantheris SV in below-the-knee procedures, an area where we see significant unmet clinical need with regard to previously available treatment options. We have been pleased with the initial commercial impact of Pantheris SV amongst existing users, and we believe IMAGE-BTK will serve to accelerate growth of this product to a wider group of interventionalists."
IMAGE-BTK includes enrollment of up to 60 patients diagnosed with peripheral disease in a vessel below the knee at six centers across the United States. The primary safety endpoint will be freedom from major adverse events after thirty (30) days and the primary efficacy endpoint will measure the technical success of Pantheris SV in reducing the residual stenosis of the target lesions on a standalone basis. Secondary effectiveness endpoints will include procedural success in decreasing residual stenosis after the combination of Pantheris SV and adjunctive therapy, freedom from target vessel revascularization at six (6) and twelve (12) months post procedure, primary patency at the target treatment site in absence of target vessel revascularization, improvement in ankle-brachial index at 30 days, 6 months, and 12-month post procedure, improvement in Rutherford class at 30 days, 6 months, and 12-month post procedure, and percentage of medial and adventitial tissue present in the excised material following histological analysis.
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 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 images 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, due 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 our future performance, expectations regarding the IMAGE-BTK study, and the impact of IMAGE-BTK. 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 Annual 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.