Avinger Announces First Patient Enrolled in its IDE Study of the Pantheris Image-Guided Atherectomy System for Treatment of In-Stent Restenosis
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced initiation of INSIGHT, 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.
Up to 140 patients will be enrolled in the INSIGHT trial at up to 20 U.S. and international centers. Sean Janzer, M.D. of Einstein Medical Center and Glen Schwartzberg, M.D. 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 X-ray fluoroscopy, and the inability to control the directionality of other treatment modalities’ mechanism of action 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.
“For many patients experiencing in-stent restenosis, treatment can result in additional harm and costs when other treatment modalities fail to provide the information and precision needed to see and treat the restenosed lesions,” said Dr. Janzer. “The Pantheris Lumivascular Atherectomy System has the potential to provide interventionalists with real-time intravascular imaging to more precisely direct plaque excision and avoid interaction with stent struts, leading to better patient outcomes in these often challenging cases.”
“Minimally invasive treatment of arterial occlusive disease has been limited in its application due to the occurrence of either over or under treatment and the subsequent complications associated with these events,” said Dr. Schwartzberg. “The revolutionary concept of real-time imaging of the the vessel lumen during an intervention will enhance an environment of safety and improved outcomes in these high risk patients. This study applies the unique Lumivascular technology to the difficult problem of in-stent restenosis, for which there is no long-term successful treatment.”
“We are pleased to initiate this new trial to gather additional data on the benefits of the Pantheris Lumivascular Atherectomy System and expand its indication for use. I was particularly excited to join Dr. Schwartzberg and the welcoming caregivers at Baton Rouge General for the first case of this important study,” said John B. Simpson, PhD., M.D., Avinger’s founder and executive chairman.
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 a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on the Lightbox console. In the past, physicians have had to rely solely on X-ray as well as tactile feedback to guide their tools while treating complicated arterial disease. With the Lumivascular approach using real-time OCT image guidance, physicians can more accurately navigate their devices to treat PAD 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). 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.