FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Rex Medical’s Peripheral Atherectomy Device Cleared

Sept. 17, 2019
A A

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.

View today's stories