February 27, 2019 — Ra Medical Systems Inc. announced a 98 percent success rate in the results from a 52-patient study using the company’s DABRA System for the treatment of above- and below-the-knee peripheral artery disease (PAD). The data was presented by Ashok Kondur, M.D., FACC, FSCAI at the 2019 Leipzig Interventional Course (LINC) in Leipzig, Germany.
The study results were overwhelmingly positive, according to the company, given the inclusion of a challenging sample of patients, all Rutherford class 4 to 6 with a high presence of calcium (80 percent of lesions had moderate to severe calcification) and 93 percent median lesion stenosis. A statistically significant difference was demonstrated in pre- and post-diameter stenosis (p<0.001), and lesion success, defined as <30 percent post diameter stenosis, was 98 percent. Furthermore, the results demonstrated statistically significant improvements in limb hemodynamic measures.
“The results of this study are extremely promising and demonstrate the positive clinical outcomes we have seen with DABRA,” said Kondur, chair, Division of Cardiology, Garden City Hospital/MSU and associate program director, Interventional Cardiology Fellowship Program, DMC Harper University Hospital, Wayne State University.
The purpose of the study was to evaluate the use of DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) in patients with above-the-knee and below-the-knee disease in a cohort of 52 patients and 111 collective lesions. Patients were treated solely with DABRA plus percutaneous coronary angioplasty (PTA), with no adjunctive stenting. Intravascular ultrasound and/or angiography was used pre- and post-treatment.
“We have seen significant changes in pre- and post-ABIs [ankle-brachial indices] and a very low complication rate with no distinct clinically or angiographically observed distal embolization,” said study lead investigator Elias Kassab, M.D., FACC, FSCAI, FACP, FASA, RPVI, FAHA, FSVM, president and CEO of Michigan Outpatient Vascular Institute and assistant professor of medicine, Wayne State University.
DABRA is a safe, versatile and simple catheter and laser system for the treatment of mixed morphology vascular blockages above- and below-the-knee. Its photochemical plaque ablating mechanism of action reduces all plaque types (calcium, thrombus and atheroma) into their fundamental chemistry with reduced mechanical, thermal and barometric trauma and minimized downstream debris.
The positive results presented at LIN 2019 are reaffirmed by Athar Ansari, M.D., DTM&H, MRCP, FACC, in his case report, Treatment of a Long, Heavily Calcified left SFA Lesion with Single-Vessel Runoff Via an Ipsilateral Antegrade Approach, published in the January issue of Endovascular Today. In the article, Ansari highlights the product’s fast and easy use with no distal embolization in yet another challenging case.
For more information: www.ramed.com