Ra Medical Systems (NYSE:RMED) announced today that it enrolled 100 subjects in a pivotal trial for its Dabra excimer laser system.
Carlsbad, California-based Ra Medical’s pivotal trial will evaluate the safety and effectiveness of Dabra as an atherectomy device for treating peripheral arterial disease (PAD).
The study aims to enroll up to 125 subjects. The company said it can’t accurately predict when enrollment will be completed due to the COVID-19 pandemic, but they’re aiming for the third quarter of 2022 with six-month follow-up to be completed in early 2023, should the study fall in line with expectations.
Ra Medical’s study will enroll subjects with PAD symptoms at up to 10 sites, with outcome measures including safety, acute technical success and clinical success.
The 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 and before any adjunctive treatment. The trial’s safety and clinical success endpoints are major adverse events at 30 days post-procedure and incidence of primary target lesion revascularization at six months.
“I want to recognize the support from our Ra Medical team and our physician investigators and staff for their diligence in reaching this significant enrollment milestone, particularly given the daunting challenges that arose from the COVID-19 pandemic,” Ra Medical Systems CEO Will McGuire said in the release. “Securing clearance for the atherectomy indication is a top priority for Ra Medical as we believe it will expand our addressable market beyond the existing clearance for crossing chronic total occlusions, or CTOs.”
