Ra Medical Bags FDA Nod for PAD Device

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by Amirah Al Idrus

The FDA cleared Ra Medical Systems’ catheter-and-laser atherectomy system for the treatment of peripheral artery disease (PAD), which commonly causes pain in the legs and can require amputation if left untreated.

PAD refers to narrowed blood vessels that restrict blood flow to the limbs. It affects about 8.5 million people in the U.S., according to the American Heart Association. Most cases can be treated with lifestyle changes and medication, but advanced cases may need stenting or bypass. Untreated, PAD can lead to gangrene and necessitate amputation.

Ra Medical’s DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation Ablation) system is designed to treat complex and diffuse blockages in the lower blood vessels. The DABRA procedure is quicker and cheaper than other treatments for arterial blockages, the company said in a statement. This could save health systems money and, ultimately, make the procedure available for more PAD patients, the company said.

“DABRA’s pivotal study demonstrated 95% success without any clinically significant adverse events,” said Ehtisham Mahmud, M.D., study chair and chief of cardiovascular medicine 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.”

“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, … and it’s effective on all types of lesions.”

Device giant Medtronic markets a range of devices for the treatment, including balloon catheters, drug-coated balloons and stents, while W.L. Gore earned an FDA nod for its expandable stent graft, the first device of its kind to be approved to treat PAD in the iliac artery.

Meanwhile, Shockwave Medical makes a device that combines traditional angioplasty with lithotripsy, the ultrasound waves typically used to break up kidney stones. The device treats calcified arteries by delivering intermittent shock wave pulses while restoring blood flow. The company raised $45 million last fall to commercialize the device.