Ra Medical Systems has announced the achievement of a milestone with the enrollment of 100 subjects in the pivotal clinical study, according to a press release. The study is to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for the treatment of peripheral arterial disease (PAD). This pivotal atherectomy study is cleared to enroll up to 125 subjects.
“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,” said Will McGuire, Ra Medical Systems CEO. “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 (CTO). Third-party research estimates that the combined CTO and atherectomy markets in the US will approximate $900 million this year.
“Due to the unpredictable nature of the pandemic, we are unable to accurately predict when we will complete study enrollment. However, our goal is to reach full enrollment during the third quarter of this year and to complete a six-month follow-up in early 2023,” he added.
The open-label pivotal atherectomy clinical trial can enroll subjects with symptoms of PAD (Rutherford Class 2-5) at up to 10 sites. Seven sites have been cleared for enrollment and one additional site is in the final phase of qualification. 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 revascularisation at six months.