Ra Medical Systems (NYSE:RMED) announced today that it won investigational device exemption approval to study use of its Dabra excimer laser system as an atherectomy device to treat peripheral vascular stenoses.
The Dabra system is designed to destroy arteriosclerotic blockages through the use of radiation ablation. The system won FDA 510(k) clearance in May 2017 for the treatment of occlusive peripheral vascular disease after the artherectomy catheter system received CE Mark approval in October 2016.
Through the investigational device exemption, Carlsbad, Calif.–based Ra Medical is set to enroll up to 100 patients with symptoms of PAD in a multicenter, open-label trial. The study’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion following Dabra treatment before adjunctive treatment.
Major adverse events at 30 days and incidence of primary target lesion revascularization at six months mark the safety and clinical success endpoints for the trial, according to a news release.
“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,” Ra Medical Systems CFO & interim CEO Andrew Jackson said in the news release. “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.”
In October, Ra Medical Systems began a voluntary recall of the Dabra laser system single-use catheters due to a calibration problem. The system experienced inconsistent performance because of catheters that fail to calibrate before procedures, which can result in a temporary delay, according to an SEC filing.
Later that month, the company shared that an internal investigation found failures surrounding its Dabra laser catheters among other shortcomings.