Ra Medical Systems receives US FDA clearance for DABRA peripheral artery disease treatment

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The US Food and Drug Administration (FDA) has granted market clearance to Ra Medical Systems—makers of excimer lasers and catheters for cardiovascular and dermatological diseases—for the company’s Destruction of Arteriosclerotic Blockages by laser Radiation Ablation (DABRA) system. The system is intended to deliver a safer, faster and cheaper solution to peripheral artery disease treatment than the market otherwise offers.

“DABRA’s pivotal study demonstrated 95% success without any clinically significant adverse events,” says Ehtisham Mahmud study chair and chief of Cardiovascular Medicine, director of Sulpizio Cardiovascular Center-Medicine and director of Interventional Cardiology at the UC San Diego School of Medicine, San Diego, USA. “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, according to a company release. Combined with its safety profile, the release states, these advantages may reduce the costs associated with treating peripheral artery disease.

“DABRA is what we have been waiting for to better treat our patients,” adds Athar Ansari, director of California Heart & Vascular Clinic, El Centro, USA. “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 is 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.”