Hansen Medical Seeks Expanded FDA Clearance for Neurological Indication for Magellan Robotic Devices

April 27, 2016—Hansen Medical, Inc. announced it has recently submitted an application for 510(k) clearance to the US Food and Drug Administration (FDA) for a neurological indication for the Magellan robotic system. If successful, the Magellan robotic system would be fully indicated for applications in peripheral vascular and neurological procedures.

Barry T. Katzen, MD, of Miami Cardiac & Vascular Institute in Miami, Florida, commented in the company’s press release, “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 embolization and other endovascular therapies.” 

According to Hansen Medical, the Magellan robotic system is commercially available in the United States and Europe, and has been used clinically in a broad variety of peripheral vascular procedures globally. It is intended to be used to facilitate navigation in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The device is designed to deliver predictability, control, and catheter stability to endovascular procedures. 

Additionally, the Magellan robotic system is designed to potentially reduce physician radiation exposure and fatigue by allowing the physician to navigate procedures while seated comfortably at a remote workstation away from the radiation field and without wearing heavy lead as required in conventional endovascular procedures, stated Hansen Medical.

Hansen Medical also announced last week that they have signed a definitive merger agreement under which Auris Surgical Robotics, Inc. will acquire Hansen.