INSIGHT Study Begins for Avinger's Pantheris Lumivascular Atherectomy System to Treat In-Stent Restenosis
October 19, 2017—Avinger, Inc. announced the initiation of the INSIGHT trial to evaluate the safety and effectiveness of the company's Pantheris Lumivascular atherectomy system for treating in-stent restenosis in lower extremity arteries.
INSIGHT is a prospective, global, single-arm, multicenter study that will enroll up to 140 patients at up to 20 United States and international centers. The study is being conducted under an investigational device exemption from the US Food and Drug Administration. Sean Janzer, MD, and Glen Schwartzberg, MD, are serving as coprincipal investigators of the study.
In the company's announcement, Dr. Janzer commented, “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. 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.”
Dr. Schwartzberg added, “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. The revolutionary concept of real-time imaging of 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.”