Ra Medical Systems, a medical device company, has enrolled the first patient in its study to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device to treat peripheral vascular stenosis.
DABRA is a minimally-invasive excimer laser system used by physicians as a tool in the endovascular treatment of vascular blockages caused by lower extremity vascular disease.
Earlier in January, the company secured the US Food and Drug Administration (FDA) clearance to begin investigational device exemption (IDE) for the study.
Ra Medical Systems CFO and Interim CEO Andrew Jackson said: “We are committed to the successful commercialisation of DABRA and we believe that initiating patient enrollment in this study is a significant step forward in achieving this goal.
“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.”
The company expects to enrol 100 patients with symptoms of PAD (Rutherford Class 2-4) for the multicentre, open-label pivotal atherectomy clinical study.
Athar Ansari, MD, FACC, director of the California Heart & Vascular Clinic in El Centro said: “My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device.
“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.”
Outcome measures of the trial include safety, acute technical success and clinical success.
The primary efficacy endpoint is the mean decrease in per cent diameter stenosis in each patient’s primary lesion measured by angiography immediately after treatment with DABRA, before any adjunctive treatment.
The safety and clinical success endpoints feature major adverse events at 30 days and incidence of primary target lesion revascularization (TLR) at six months.
Ra Medical Systems sells excimer lasers and catheters to treat dermatological and vascular diseases.