The FDA has granted 510(k) clearance to Hansen Medical's Magellan Robotic System, including the catheter and accessories.
The Mountain View, Calif.-based company will commence commercialization at selected centers in the U.S. immediately, with a full launch expected later in the year.
The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The system has the potential to provide vascular surgeons and other interventionalists with the ability to perform procedures, while allowing the physician to be seated away from the radiation source.
The Magellan system received a CE Mark in the European Union last year, and the company has commenced a commercial launch in that region. In addition, the system also has been approved in Australia, and is pending approval in Canada.