Ra Medical Enrolls First Patient in Atherectomy Clinical Study

Ra Medical Systems Inc., a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces enrollment 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, M.D., FACC, director of the California Heart & Vascular Clinic in El Centro, Calif., and the study chairman. “We are thrilled to be the first center to begin enrollment in the atherectomy study, which represents an important next step in expanding the DABRA indications for use.”
 
“We are committed to the successful commercialization of DABRA and we believe that initiating patient enrollment in this study is a significant step forward in achieving this goal,” said Andrew Jackson, Ra Medical Systems chief financial officer. “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 U.S. Food and Drug Administration in January. This multicenter, open-label pivotal atherectomy clinical study will enroll up to 100 patients with symptoms of peripheral artery disease (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 revascularization (TLR) at six months will be the safety and clinical success endpoints.
 
DABRA is Ra Medical’s minimally invasive excimer laser system used by physicians as a tool in the endovascular treatment of vascular blockages resulting from lower extremity vascular disease, a form of PAD, both above and below the knee. DABRA reduces all plaque types into their fundamental chemistry, such as proteins, lipids and other chemical compounds, eliminating blockages by essentially dissolving them without generating potentially harmful particulates. DABRA employs photoablation, or the removal of arterial tissue by using photons to clear blockages by breaking the bonds of the obstructing plaque.