Hansen Medical, a developer of robotic technology for 3D control of catheter movement, announced July 26 that it has completed the European Union conformity assessment procedure and affixed a CE mark on its Magellan robotic system.
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, according to the Mountain View, Calif.-based company.
While the CE mark enables Hansen to commence a full launch of Magellan in the European Union, the company will commence commercialization at selected centers initially, with a full launch expected in the first half of 2012.
The Magellan system is designed for use with the NorthStar robotic catheter and related accessories, which have not yet received CE marks. Also, in the U.S., the Magellan robotic system does not have FDA clearance and is not commercially available. The company submitted a 510(k) pre-market notification application for the Magellan robotic system, the NorthStar robotic catheter and accessories to the FDA earlier this year.