February 27, 2020
Enrollment Begins in Pivotal Atherectomy Study of Ra Medical’s Dabra Excimer Laser System
February 27, 2020—Ra Medical Systems, Inc. announced enrollment of the first patient in a pivotal study to evaluate the safety and effectiveness of its Dabra excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses. The company received investigational device exemption approval for the study from the FDA in January 2020.
Athar Ansari, MD, Director of the California Heart & Vascular Clinic in El Centro, California, serves as the Study Chairman. Dr. Ansari commented in the company’s announcement, “My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device. We are thrilled to be the first center to begin enrollment in the atherectomy study, which represents an important next step in expanding the DABRA indications for use.”
According to Ra Medical, this multicenter, open-label, pivotal, atherectomy clinical study will enroll up to 100 patients with symptoms of peripheral artery disease (Rutherford class 2–4). Outcome measures include safety, acute technical success, and clinical success.
The trial’s primary efficacy endpoint is the mean reduction in percent-diameter stenosis in each patient’s primary lesion as measured by angiography immediately after treatment with Dabra, before any adjunctive treatment. Major adverse events at 30 days and incidence of primary target lesion revascularization at 6 months will be the safety and clinical success endpoints, stated the company.