Ra Medical Systems, Inc , a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces approval from the U.S. FDA that the Company has provided sufficient data to support initiating an investigational device exemption (IDE) to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses. In May 2017, DABRA received FDA 510(k) clearance for use in ablating a channel in occlusive peripheral vascular disease (PAD).
“We are delighted the FDA has granted this IDE allowing us to pursue an atherectomy indication for DABRA and anticipate enrolling the first patient into the trial in the next few months,” said Andrew Jackson, Ra Medical Systems CFO and Interim CEO. “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. Atherectomy with mechanical devices can cause trauma to vessel walls, often resulting in restenosis or a return of the blockage months following the procedure.”
The multicenter, open-label trial will enroll up to 100 patients with symptoms of PAD (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 following treatment with DABRA, before any adjunctive treatment. Major adverse events at 30 days and incidence of primary target lesion revascularization (TLR) at six months will be the safety and clinical success endpoints.
DABRA is Ra Medical’s minimally invasive excimer laser system used by physicians as a tool in the endovascular treatment of vascular blockages resulting from lower extremity vascular disease, a form of PAD, both above and below the knee. DABRA 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. DABRA employs photochemical ablation, or the removal of arterial tissue by using photons to clear blockages by breaking the bonds of the obstructing plaque. Unlike many treatments for PAD that may damage the arterial wall, DABRA quickly and photochemically dissolves plaque with minimal vascular trauma.
About Ra Medical Systems
Ra Medical Systems commercializes excimer lasers and catheters for the treatment of vascular and dermatological diseases. In May 2017, the DABRA excimer laser system received FDA 510(k) clearance in the U.S. for crossing chronic total occlusions, or CTOs, in patients with symptomatic infrainguinal lower extremity vascular disease with an intended use for ablating a channel in occlusive peripheral vascular disease. Pharos excimer laser system is FDA-cleared and is used as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. DABRA and Pharos are both based on Ra Medical’s core excimer laser technology platform and deploy similar mechanisms of action. Ra Medical manufactures DABRA and Pharos excimer lasers and catheters in a 32,000-square-foot facility located in Carlsbad, Calif. The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in controlled environments.