BD announces 510(k) clearance of expanded indications for the Rotarex atherectomy system


BD recently announced it has received 510(k) clearance for expanded indications from the US 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 Rotarex atherectomy system is quick and efficient for treating arterial lesions,” said Prakash Krishnan, a cardiologist at the Icahn School of Medicine at Mount Sinai in New York, USA. “With 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 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.

“I have had the ability to use the Rotarex atherectomy system for over 10 years both within and outside the USA,” said Miguel Montero-Baker, a vascular surgeon at Baylor College of Medicine in Houston, USA. “This indication expansion is exciting and will allow me to utilise a device I trust to care for my complex PAD patients.”


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