Ra Medical Systems recently announced that enrolment has reached 95 patients 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). The company also reported approval from the US Food and Drug Administration (FDA) to increase enrolment from 100 to 125 patients.
“Our request to increase subject enrolment in the atherectomy trial was primarily due to subject fallout for follow-up visits during the ongoing COVID-19 pandemic. To this end, we are pleased the FDA has approved our protocol amendment,” said Will McGuire, Ra Medical Systems CEO. “We are excited about the opening of two additional clinical sites in late 2021, both with lead investigators who are highly regarded interventional cardiologists, which brings the number of sites qualified for this trial to seven. We expect one additional site, also led by an interventional cardiologist thought leader, to be qualified in the near term. The opening of these new sites is encouraging, yet due to the pandemic we are unable to provide a precise timeline for full enrolment.”
“There is no question that obtaining FDA clearance for an atherectomy indication for the Dabra excimer laser system is among our top priorities,” he added. “We significantly expand our addressable market with this clearance. A third-party research group estimates the value of the combined chronic total occlusion (CTO) and atherectomy markets in the USA at approximately US$900 million for 2022, with atherectomy representing more than US$700 million.”
Dabra has been cleared by the FDA for crossing CTOs in patients with symptomatic infrainguinal lower extremity vascular disease and has an intended use for ablating a channel in occlusive peripheral vascular disease. The FDA defines atherectomy to include a prespecified improvement in luminal patency.
The open-label pivotal atherectomy clinical trial can enrol 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 revascularisation at six months.