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. According to a news release, the “unpredictable nature” of the COVID-19 pandemic means the company can’t accurately predict when enrollment will be completed, but the aim is 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 prim…