Ra Medical Systems has announced enrolment of the first patient in its pivotal study to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses.
“My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device,” said Athar Ansari, director of the California Heart & Vascular Clinic (El Centro, USA) and the study chairman. “We are thrilled to be the first centre to begin enrolment in the atherectomy study, which represents an important next step in expanding the DABRA indications for use.”
“We are committed to the successful commercialisation of DABRA and we believe that initiating patient enrolment in this study is a significant step forward in achieving this goal,” said Andrew Jackson, Ra Medical Systems CFO and interim CEO. “Furthermore, we have built a team of experienced, motivated and enthusiastic physician partners and employees to execute on this goal and we look forward to providing updates on our progress.”
Ra Medical received investigational device exemption (IDE) approval for the study from the FDA in January 2020. This multicentre, open-label pivotal atherectomy clinical study will enrol up to 100 patients with symptoms of PAD (Rutherford Class 2–4). 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, before any adjunctive treatment. Major adverse events at 30 days and incidence of primary target lesion revascularisation (TLR) at six months will be the safety and clinical success endpoints.