January 21, 2020
Ra Medical Gains IDE to Conduct Pivotal Laser Atherectomy Trial of the DABRA System
January 21, 2020—Ra Medical Systems, Inc. announced approval from FDA that the company has provided sufficient data to support an investigational device exemption trial to evaluate the safety and effectiveness of the company’s DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses.
The company stated that the multicenter, open-label trial 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 the DABRA system and before any adjunctive treatment. The safety and clinical success endpoints will be major adverse events at 30 days and incidence of primary target lesion revascularization at 6 months.
In May 2017, DABRA received FDA 510(k) clearance for use in ablating a channel in occlusive peripheral vascular disease. The DABRA system produces minimal vascular trauma because of its use of photochemical ablation that dissolves plaque into its molecular components, advised the company.
According to Ra Medical, the DABRA excimer laser system is used for the endovascular treatment of vascular blockages resulting from lower extremity vascular disease, both above and below the knee. The device reduces all four plaque types into their fundamental chemistry, such as proteins, lipids, and other chemical compounds, eliminating blockages by essentially dissolving them without generating potentially harmful particulates. Photochemical ablation removes arterial tissue by using photons to clear blockages by breaking the bonds of the obstructing plaque.