October 6, 2021 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced it has received 510(k) clearance for expanded indications from the 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 unique mechanism of action of Rotarex Atherectomy Device has enabled the simultaneous treatment of both plaque and thrombus, the company says.