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October 6, 2021
BD’s Rotarex Atherectomy System Cleared for Expanded Indications
October 6, 2021—BD (Becton, Dickinson and Company) announced it has received FDA 510(k) clearance for expanded indications for its Rotarex atherectomy system for treatment within peripheral arteries fitted with stents, stent grafts, and native or artificial bypasses in patients with peripheral artery disease (PAD).
Rotarex, which is a rotational excisional device built to remove and aspirate varying lesion morphologies including plaque and thrombus in the peripheral arteries, was previously cleared for use in native arterial vessels.
“I have had the ability to use the Rotarex atherectomy system for over 10 years both within and outside the United States,” commented vascular surgeon Miguel Montero-Baker, MD, in the company’s press release. “This indication expansion is exciting and will allow me to utilize a device I trust to care for my complex PAD patients.”
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