The FDA granted 510(k) clearance to Rex Medical’s Revolution peripheral atherectomy system, a device designed to remove blood clots from peripheral arteries of patients with atherosclerosis.
The device has multiple above and below-the-knee uses, including for multiple plaque forms ranging from clots and soft plaque to severely calcified lesions.
The system uses a 72-watt power supply similar to a laptop charger, requires no capital equipment and minimal set up time, the company said.
