FDA Clears Ra Medical’s DABRA Atherectomy System to Treat PAD

May 30, 2017

Ra Medical Systems, Inc. announced that the US Food and Drug Administration has granted market clearance for the company’s DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) atherectomy system with catheter for the treatment of peripheral artery disease. In October 2016, the company announced that the DABRA system was approved in Europe.

Ehtisham Mahmud, MD, Chair of the pivotal study of the device, explained in the company’s announcement, “DABRA’s pivotal study demonstrated 95% success without any clinically significant adverse events. Furthermore, the DABRA catheter is unique in its ability to cross chronic total occlusions without having to cross the lesion with a wire,and it also debulks and modifies arterial blockages, making it an invaluable clinical tool.” Dr. Mahmud is Chief of Cardiovascular Medicine, Director of Sulpizio Cardiovascular Center-Medicine, and Director of Interventional Cardiology at the UC San Diego School of Medicine in San Diego, California.

About Ra Medical Systems
Ra Medical Systems was founded in 2002 to commercialize excimer lasers for the treatment of dermatologic and cardiovascular diseases. Its flagship product, Pharos, launched in 2004 and revolutionized the dermatology world with its technology and game-changing business model.

Today, Ra Medical Systems continues to make history as it commercializes the DABRA catheter and laser cardiovascular system.