CE Mark Approved for Hansen Medical's Magellan 6-F Robotic Catheter

November 3, 2014—Hansen Medical, Inc. announced that the company’s Magellan 6-F robotic catheter has received European CE Mark approval for use in the peripheral vasculature. This allows the company to market the Magellan 6-F device in Europe and other countries that recognize the CE Mark. In February 2014, the company announced US Food and Drug Administration 510(k) clearance for the Magellan 6-F robotic catheter, which is commercially available in the United States.

According to the company, the 6-F robotic catheter’s new dual-bend technology enables independent robotic control of two separate bend sites on a single catheter, providing for precise robotic navigation and control. The small 6-F outer diameter enables use of the Magellan robotic system in smaller vessels in the peripheral vasculature and broadens use of intravascular robotics technology to physicians who may prefer a smaller-diameter vessel insertion site.

“This is a significant milestone in the development of intravascular robotics,” commented Mo Hamady, MD, in the company’s press release. Dr. Hamady is from Imperial College London in the United Kingdom. He continued, “Robotic catheters have the potential to provide physicians with enhanced control and navigation, especially in tortuous vessels. With this smaller-diameter robotic catheter, we can now broaden the types of procedures we are able to perform with the Magellan robotic system. The new 6-F robotic catheter increases the clinical applications to many interventional vascular therapies involving smaller vessels, including cancer treatment, women's health, and lower limb treatment.”

The Magellan robotic system drives the Magellan robotic catheters during endovascular procedures. Magellan is designed to offer procedural predictability, control, and catheter stability to physicians as they remotely navigate the robotic catheter through the vasculature. Magellan's remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians' radiation exposure and procedural fatigue, stated the company.