May 30, 2017 — The U.S. Food and Drug Administration (FDA) announced that it has granted market clearance to Ra Medical Systems for the company’s DABRA (Destruction of Ateriosclerotic Blockages by laser Radiation Ablation) System.
More than 200 million people worldwide, including approximately 8.5 million Americans, suffer from peripheral artery disease (PAD), a life-threatening condition in which the arteries that carry blood from the heart to the legs and arms narrow and become blocked. In the United States and Europe, PAD is responsible for approximately 240,000 amputations every year. Nearly one-quarter of these patients die within 30 days and almost half within a year of their limb amputation.
“DABRA’s pivotal study demonstrated 95 percent success without any clinically significant adverse events,” said Ehtisham Mahmud, M.D., study chair and chief of cardiovascular medicine, director of Sulpizio Cardiovascular Center-Medicine and director of interventional cardiology at the University of California (UC) San Diego School of Medicine. “Furthermore, the DABRA Catheter is unique in its ability to cross chronic total occlusions (CTOs) without having to cross the lesion with a wire, and it also debulks and modifies arterial blockages, making it an invaluable clinical tool.”
Compared to other treatments for arterial blockages, Ra Medical Systems’ DABRA has a shorter procedure time and is less expensive. Combined with its safety profile, these DABRA advantages may reduce the costs associated with treating PAD and ultimately lead to greater patient access to, and success with, interventional procedures instead of limb amputation.
“DABRA is what we have been waiting for to better treat our patients,” added Athar Ansari, M.D., director of California Heart & Vascular Clinic. “It is a two-in-one. You cross the blockage and remove the plaque from the artery. It is safe, because it stays in the patient’s true lumen and does not go subintimal or perforate – common complications of other devices – and it’s effective on all types of lesions. It is revolutionary wireless technology and effective in cases in which other devices have failed. DABRA should be part of every cardiovascular catheter lab’s armentarium.”
For more information: www.ramed.com