Ra Medical Systems (NASDAQ:RMED) enrolled the first patient in its pivotal study of the DABRA excimer laser system for the treatment of peripheral vascular stenoses.
DABRA is an atherectomy device that uses photoablation to reduce arterial plaque. It is designed to treat vascular blockages resulting from lower extremity vascular disease.
The study will enroll up to 100 patients with symptoms of peripheral artery disease. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion.
“My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device,” Dr. Athar Ansari, director of the California Heart & Vascular Clinic and study chairman, said in a statement.
“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,” he added.
