Hansen Medical's Magellan 10-F Robotic Catheter Receives CE Mark Approval

April 14, 2015—Hansen Medical, Inc. announced that the company’s Magellan 10-F robotic catheter has received European CE Mark approval for use in the peripheral vasculature. The 10-F device is the latest addition to Hansen Medical’s family of robotic catheters used with the Magellan robotic system. 

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

In the company’s press release, Thomas Nolte, MD, commented, “The Magellan 10-F robotic catheter is an important advance for intravascular robotics and the Magellan robotic system. The larger inner lumen will enable physicians to precisely deliver therapeutic devices through a stable, robotic catheter platform in many more vascular procedures. In particular, many complex endovascular aneurysm repairs and lower extremity arterial revascularizations involve delivery of stents, balloons, or other devices requiring a 7-F catheter inner lumen.” Dr. Nolte is Director of the Vascular Center at the Heart & Vascular Center in Bad Bevensen, Germany.

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. Magellan is designed to deliver predictability, control, and catheter stability to endovascular procedures. The system employs an open architecture designed to allow for the subsequent use of many therapeutic devices. Additionally, it 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.