Ra Medical Systems Receives FDA Clearance for Laser Ablation

In an effort to battle Peripheral Artery Disease (PAD), the leading cause of limb amputations, the FDA has granted market clearance to laser developer Ra Medical Systems Inc., makers of excimer lasers and catheters for cardiovascular and dermatological diseases, for the company’s laser ablation system.

The system — destruction of arteriosclerotic blockages by laser radiation ablation (DABRA) — quickly and economically treats arterial blockages.

More than 200 million people worldwide suffer from 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 U.S. and Europe, PAD is responsible for approximately 240,000 amputations every year, and nearly one-quarter of them 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 Dr. Ehtisham Mahmud, study chair, chief of cardiovascular medicine and director of the Sulpizio Cardiovascular Center of Medicine, as well as the director of interventional cardiology at the 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.”

Ra Medical Systems develops excimer lasers and catheters for the treatment of dermatologic and cardiovascular diseases.