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BD Says Rotarex Atherectomy System Receives Expanded 510(k) Clearance From FDA - Quick Facts

Medical technology company Becton, Dickinson and Co. or BD (BDX) announced Wednesday that it has received 510(k) clearance for expanded indications from the U.S. Food and Drug Administration (FDA) for the Rotarex Atherectomy System.

The Rotarex Atherectomy System is a rotational excisional device that is built to remove and aspirate varying lesion morphologies including plaque and thrombus in the peripheral arteries.

The Rotarex System, already cleared for use in native arterial vessels, now has the expanded indications to treat within peripheral arteries fitted with stents, stent grafts, and native or artificial bypasses.

The FDA clearance of the Rotarex Atherectomy System's new expanded indications follows more than 10 years of real-world clinical experience involving the treatment of thousands of patients globally.

Now, physicians can use a proven tool to address some of their most challenging peripheral arterial disease (PAD) lesions, including the treatment of in-stent restenosis.

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