Avinger releases updated data from IMAGE-BTK study in webinar

Avinger (AVGR) hosted a physician-focused webinar entitled, “New Approaches to Treating Peripheral Artery Disease Below-the-Knee and Promising New BTK Data.” The webinar featured key opinion leaders in the field of vascular intervention from different specialties and geographies as follows: Dr. Michael Lichtenberg, an angiologist and the Chief Medical Officer and Director of the Angiology Department and Vascular Center at the Arnesberg Clinic in Arnesberg, Germany presented on the challenges of treating below-the-knee vascular disease and offered a future perspective on treating BTK and critical limb ischemia. Dr. Lichtenberg has over 20 years of experience in endovascular interventions and served as the Managing Director and President of the German Society for Angiology. Dr. Thomas Davis, an interventional cardiologist, Director of Cardiovascular Research at St. John Hospital and Medical Center in Detroit, Michigan and Avinger’s CMO, provided an overview of the Pantheris SV device and reviewed updated data from the IMAGE-BTK study – a prospective, global, multi-center trial studying the treatment of BTK lesions with Pantheris SV. Pantheris SV, Avinger’s proprietary technology for PAD interventions in small diameter peripheral vessels, features an intravascular image-guidance system combined with a targeted plaque excision mechanism for safe and durable outcomes. Dr. Davis has over three decades of clinical practice and leadership in cardiovascular medicine and has pioneered the use of cutting-edge interventional technologies to treat lower extremity arterial disease. He has served on several scientific advisory boards, on faculty at national conferences, as an investigator in multiple clinical trials, and has authored multiple publications. Dr. Philip Auyang, a board-certified vascular surgeon specializing in both vascular and endovascular surgery in Houston, Texas, shared a case study featuring the minimally invasive treatment of multi-level PAD with Pantheris in a patient with recurrence of a blockage within stents previously placed above-the-knee, and stenoses below-the-knee. He treats all forms of arterial and venous disorders and has authored several publications on the treatment of vascular disease in the Journal of Vascular Surgery and Annals of Vascular Surgery. In his presentation, Dr. Davis presented updated interim data from IMAGE-BTK, a post-market study designed to evaluate the safety and efficacy of Pantheris SV in below-the-knee procedures, historically an extremely challenging subset of PAD interventions. The study enrolled 51 patients with 58 lesions treated, and now includes follow-up data collected on 45 patients at 6 months and 33 patients at 12 months. In terms of safety, the data showed 100% freedom from major adverse events at 30 days, 0% all-cause mortality at 30 days, and no major unplanned amputations. Follow-up of these patients at 12-months yielded 97% freedom from target lesion revascularization, a measure of restenosis, and 94% primary patency as assessed by duplex ultrasound.