US FDA grants 510(k) clearance for BD Rotarex System expanded indications

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Becton, Dickinson and Company’s (BD) Rotarex Atherectomy System expanded indications.

A rotational excisional device, the Rotarex Atherectomy System is designed to remove and aspirate varying lesion morphologies, including plaque and thrombus, in peripheral arteries.

It has already secured clearance for use in native arterial vessels.

Now, the device has expanded indications for treatments inside peripheral arteries that are fitted with stent grafts, stents, and native or artificial bypasses.

The Rotarex Atherectomy System has a small plug-and-play capital component and reusable handle, which makes it easy to use and simple to set up. It does not require infusions or catheter cleanout.

It is claimed to be the first and only atherectomy and thrombectomy device which is indicated to treat in-stent restenosis in the US.

The FDA clearance of the device’s expanded indication for treatments within peripheral arteries comes after more than ten years of real-world clinical experience.

The clearance will allow physicians to use the Rotarex Atherectomy System to address some of their most challenging peripheral arterial disease (PAD) lesions.

BD peripheral intervention worldwide president Paddy O’Brien said: “The additional indications provide physicians a one-of-a-kind, ideal solution for treating complex lesions associated with PAD and further demonstrates our responsibility as an industry to develop innovative technologies to help with the fight against PAD.”

The device’s unique mechanism enables the simultaneous treatment of plaque and thrombus.

In June, the FDA expanded its 510(k) clearance for the BD PeritX Peritoneal Catheter System to drain symptomatic, recurrent, non-malignant ascites.

Source: https://www.medicaldevice-network.com/news/us-fda-510k-clearance-bd-rotarex-system/