FDA Clears Hansen Medical's Magellan 10-F Robotic Catheter

July 1, 2015—Hansen Medical, Inc. announced that it received US Food and Drug Administration (FDA) 510(k) clearance for its Magellan 10-F robotic catheter for use in the peripheral vasculature. In April, the company announced European CE Mark approval for the device.

According to Hansen Medical, the 10-F robotic catheter allows for independent, robotic control of two telescoping catheters: an outer guide and an inner leader catheter. The guide catheter has a 10-F outer diameter and features the largest inner lumen (7 F) in the Magellan catheter family, which enables delivery of therapeutic devices through the robotic catheter in a broader range of endovascular procedures.

Hansen Medical’s Magellan robotic system is intended to be used to facilitate navigation in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, advised the company.

Fred Weaver, MD, who is Chief of Vascular Surgery and Endovascular Therapy at Keck Hospital of the University of Southern California, commented in the company’s press release, “We have been eagerly anticipating having access to the Magellan 10-F robotic catheter. Our team has found significant clinical value in the Magellan system to predictably navigate tortuous vascular anatomy and provide a stable platform during treatment. The 10-F catheter, with its larger inner lumen, will enable us to broaden our use of Magellan to include many additional procedures in which the delivery of stents, balloons, or other devices requires a 7-F catheter inner lumen.”