Data Presented for Ra Medical Systems' DABRA Excimer Laser System to Treat PAD
February 20, 2019—Ra Medical Systems, Inc. announced results from a single-center, 52-patient cohort study using the company’s DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) excimer laser system for the treatment of above- and below-the-knee peripheral artery disease. The data were first presented by Ashok Kondur, MD, at LINC 2019, the Leipzig Interventional Course held January 22–25 in Leipzig, Germany.
The company stated that DABRA is a catheter and laser system for the treatment of mixed morphology vascular blockages above and below the knee. The device's photochemical plaque-ablating mechanism of action reduces all plaque types (calcium, thrombus, atheroma) into their fundamental chemistry with reduced mechanical, thermal, and barometric trauma and minimized downstream debris.
The purpose of the study was to evaluate the use of DABRA in patients with above- and below-the-knee disease in a cohort of 52 patients with 111 collective lesions. Patients were solely treated with DABRA plus percutaneous transluminal angioplasty, with no adjunctive stenting. Intravascular ultrasound and/or angiography was used pre- and posttreatment.
According to Ra Medical Systems, the study results were overwhelmingly positive, given the inclusion of a challenging sample of patients—all Rutherford class 4 to 6 with a high presence of calcium (80% of lesions had moderate to severe calcification) and 93% median lesion stenosis.
A statistically significant difference was demonstrated in pre- and postprocedural diameter stenosis (P < .001), and lesion success, defined as ≤ 30% postprocedural stenosis, was 98%. Furthermore, the results demonstrated statistically significant improvements in limb hemodynamic measures.
The study's Lead Investigator, Elias Kassab, MD, commented, “We have seen significant changes in pre- and post-ankle brachial indices and a very low complication rate with no distinct clinically or angiographically observed distal embolization.”
The company noted that Athar Ansari, MD, reaffirmed DABRA's performance in a case report, Treatment of a Long, Heavily Calcified left SFA Lesion With Single-Vessel Runoff Via an Ipsilateral Antegrade Approach, which was published as a company-sponsored Featured Technology article in Endovascular Today (2019;18:92–93).