Ra Medical Systems (RMED) Reports Increased Enrollment in Pivotal Atherectomy Clinical Trial
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Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces an increase in enrollment in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for the treatment of peripheral arterial disease (PAD). A total of 42 subjects have been enrolled as of April 19, 2021.
“We are encouraged by recent progress in our atherectomy trial with 12 subjects enrolled since our last update in mid-March,” said Will McGuire, Ra Medical Systems CEO. “Five clinical sites are cleared for enrollment in this study with two additional sites currently in various stages of the qualification process.”
The DABRA excimer laser system received U.S. FDA 510(k) clearance in May 2017 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. The FDA defines atherectomy to include a prespecified improvement in luminal patency. Third-party research estimates the value of the combined CTO and atherectomy markets in the U.S. at approximately $900 million for 2021, with atherectomy representing more than $750 million.
The open-label pivotal atherectomy clinical trial can enroll up to 100 subjects with symptoms of PAD (Rutherford Class 2-5) at up to 10 sites. 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 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 post-procedure.
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