FDA Clears Hansen's Magellan 6-F Robotic Catheter

February 11, 2014—Hansen Medical, Inc. (Mountain View, CA), announced it has received US Food and Drug Administration clearance for its smaller-diameter Magellan 6-F robotic catheter for peripheral vascular interventions. The new device is the latest addition to the company’s family of catheters for use with the Magellan robotic system.

Hansen Medical will begin a limited release of the Magellan 6-F robotic catheter, collecting clinical and procedure data over a broad set of cases over the next several months. The company anticipates a more wide-scale release later in 2014.

According to Hansen Medical, the Magellan 6-F robotic catheter’s new features include dual-bend technology, enabling independent robotic control of two separate bend sites on a single catheter for use in smaller vessels in the peripheral vasculature and by interventionists who may prefer a smaller-diameter vessel insertion site. The current Magellan 9-F robotic catheter is designed as a telescoping device with two independently controlled robotic catheters.

In the company’s press release, Barry T. Katzen MD, founder and Medical Director of Baptist Cardiac & Vascular Institute, commented, “This is a major development for Hansen Medical and intravascular robotics. With this lower profile robotic catheter, we can now increase the number and types of procedures we perform with the Magellan robotic system. The new catheter expands the clinical applications to many interventional vascular therapies involving smaller vessels, including cancer treatment, women's health, and lower limb treatment.”

Used with the Magellan robotic system, the Magellan robotic catheters are designed to allow improved procedural predictability, control, and catheter stability during navigation of a patient’s peripheral vasculature. The catheters then provide a conduit for manual placement of therapeutic devices for the treatment of vascular disease. The Magellan robotic system allows the interventionist to navigate through the vasculature while seated at a remote workstation, away from the radiation field, potentially reducing physician radiation exposure and fatigue, according to the company.