Hansen Medical files 510(k) application to US FDA for Magellan neurological indication

Hansen Magellan robotic system_main
Hansen’s Magellan robotic system

Hansen Medical has recently submitted a 510(k) application to the US Food and Drug Administration for a neurological indication for the Magellan Robotic system.

If successful, the system would be fully indicated for applications in peripheral vascular and neurological procedures in the USA.

“Our experience in performing robotically assisted carotid stent procedures has shown that there could be important advantages for neuro applications including many of the benefits we have seen in other applications, like embolisation and other endovascular therapies,” says Barry T Katzen of Miami Cardiac & Vascular Institute in Miami, USA.