Ra Medical enrolls 100th patient in clinical study of Dabra laser system

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…

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Ra Medical Systems wins patent for laser ablation support catheter

Ra Medical Systems today said it received a patent from the U.S. Patent and Trademark Office for a support catheter used with a small flexible liquid core catheter for laser ablation.

The Carlsbad, California-based company was granted its 10th patent for the support catheter that is to be used in conjunction with the Dabra liquid core ablation catheter. Ra Medical designed it for use in laser ablation of arterial plaque blockages to restore blood flow.

Get the full story on our sister site, Medical Tubing + Extrusion.

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