Ra Medical Announces Progress of the Next-Generation DABRA Excimer Laser System

June 29, 2021—Ra Medical Systems, Inc. announced that enrollment in the pivotal atherectomy clinical trial with its DABRA excimer laser system is now at 62 patients, including 42 patients enrolled since the beginning of 2021. In October 2020, the company advised that the trial enrollment was resumed after being paused in February 2020 due to the COVID-19 pandemic.

Additionally, the company advised that it is progressing with finalizing the design of its next-generation, guidewire-compatible DABRA catheter after a recent 2-day, hands-on workshop with interventionalists who evaluated prototypes of the device.

According to Ra Medical Systems, the open-label pivotal atherectomy clinical trial is expected to enroll up to 100 patients with symptoms of peripheral artery disease (Rutherford class 2-5) at up to 10 sites in the United States. 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 after treatment with DABRA and before any adjunctive treatment. The trial’s safety and clinical success endpoints are major adverse events at 30 days postprocedure and incidence of primary target lesion revascularization at 6 months postprocedure.

“I’m delighted Ra Medical Systems has made such significant forward progress in bringing a guidewire-compatible platform of their next-generation catheter to the market, while also advancing toward regulatory clearance for the atherectomy indication,” commented Tom Davis, MD, in the company’s announcement. Dr. Davis, an interventional cardiologist practicing at Eastlake Cardiovascular, PC, in St. Clair Shores, Michigan, continued, “Achievement on both these milestones are critical and positive steps toward their commercialization success and represents a promising technology for expanded patient care options in my practice.”

Also in the press release, Will McGuire, Ra Medical Systems CEO, stated, “We are grateful for the valuable feedback we have received from our physician advisors as they are leaders in their field and represent the customer base for our excimer laser system. Also, the current pace of enrollment in our atherectomy trial is encouraging, as we believe regulatory clearance for this indication will better position Ra Medical to address the large and growing market for treating vascular disease.”