The FDA has Approved new Indications for BD’s Rotarex Atherectomy Device

BD announced this week that their Rotarex atherectomy device has gained FDA 510(k) approval for additional indications.The is a rotating excision device created by BD in Franklin Lakes, New Jersey that eliminates and aspirates various lesion shapes in the peripheral arteries.

“The Rotarex atherectomy method is fast and efficient for treating arterial lesions,” stated Dr. Prakash Krishnan, a New York-based cardiologist. “With the capacity to do both atherectomy and thrombectomy, it is now a fantastic product for treating in-stent restenosis.” Rotarex has been a fantastic tool in my practice, and I am really thrilled about these additional indications.”

The device’s extended indications include peripheral arteries with stents, stent grafts, and native or artificial bypasses. It has previously been approved for use in natural arterial arteries.Dr. Miguel Montero-Baker, a vascular surgeon in Houston, said in a news release, “I have had the option to employ the Rotarex atherectomy device for over 10 years both within and outside the United States.” “This indication extension is wonderful since it will enable me to use a device I trust to care for my difficult PAD patients.”

Atherectomy and thrombectomy are minimally invasive treatments that remove plaque and blood clot buildup in order to improve blood flow in sick regions. The Rotarex mechanics allow it to treat plaque and thrombus at the same time.”The additional indications provide physicians with a one-of-a-kind, ideal solution for treating complex lesions associated with peripheral arterial disease and further demonstrates our industry’s responsibility to develop innovative technologies to aid in the fight against PAD,” said Paddy O’Brien, BD’s global president of peripheral intervention.