FDA Grants Market Clearance to New Peripheral Artery Disease Treatment

The Food and Drug Administration (FDA) has granted market clearance to Ra Medical Systems’ DABRA System. DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) changes the paradigm of vascular treatments clinically and economically.

More than 200 million people worldwide suffer from Peripheral Artery Disease, 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 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.