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www.fdanews.com/articles/204819-bd-gets-additional-510k-clearance-for-its-rotarex-atherectomy-system

BD Gets Additional 510(k) Clearance for Its Rotarex Atherectomy System

October 13, 2021

Becton Dickinson (BD) has received 510(k) marketing clearance from the FDA for its Rotarex atherectomy system for new indications.

The rotational device is used for removing various types of lesions, plaque and blood clots from the peripheral arteries.  The minimally invasive technique offers an alternative to balloon angioplasty, which is used to widen narrowed or obstructed arteries or veins.

Rotarex was previously cleared for use in arterial vessels. The new clearance is for expanded indications to treat patients whose peripheral arteries are fitted with stents, stent grafts and native or artificial bypasses.

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