BD this week announced that it has received FDA 510(k) clearance for expanded indications for its Rotarex atherectomy system.
Franklin Lakes, N.J.-based BD designed the Rotarex as a rotational excision device that removes and aspirates varying lesion morphologies in the peripheral arteries.
“The Rotarex atherectomy system is quick and efficient for treating arterial lesions,” said Dr. Prakash Krishnan, a cardiologist based in New York. “With the ability to use it for both atherectomy and thrombectomy, it is now a great product to be able to treat in-stent restenosis. Rotarex has been a great device for me to have in my practice, and I am excited about these new indications.”
The expanded indications on the device cover peripheral arteries fitted with stents, stent-grafts and native or artificial bypasses. It 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 U.S.,” Dr. Miguel Montero-Baker, a vascular surgeon in Houston, said in a news release. “This indication expansion is exciting and will allow me to utilize a device I trust to care for my complex PAD patients.”
Atherectomy and thrombectomy procedures are minimally invasive solutions that remove plaque and blood clot build-up to increase blood flow through diseased areas. The mechanisms of the Rotarex allow the device to treat plaque and thrombus simultaneously.
“The additional indications provide physicians a one-of-a-kind, ideal solution for treating complex lesions associated with peripheral arterial disease and further demonstrates our responsibility as an industry to develop innovative technologies to help with the fight against PAD,” said Paddy O’Brien, worldwide president of peripheral intervention for BD.