Ra Medical Systems received an investigational device exemption from the FDA to evaluate the safety and effectiveness of its DABRA excimer laser system for treatment of narrowing of the peripheral arteries.
DABRA previously received 510(k) clearance for use in removing blockages in peripheral vascular disease.
The multicenter trial will enroll up to 100 patients with symptoms of peripheral arterial disease. Major adverse events at 30 days and incidence of primary target lesion revascularization at six months will be the safety and clinical success endpoints.
"We believe DABRA produces minimal vascular trauma due to its unique use of photochemical ablation that dissolves plaque into its molecular components, which may make DABRA a preferred treatment,” said Ra Medical Systems CFO and Interim CEO Andrew Jackson.