FDA clearance of the Magellan 6Fr Robotic Catheter

The medical device features novel dual-bend technology, enabling independent robotic control of two separate bend sites on a single catheter.

February 17, 2014
Manufacturing Group

Mountain View, California – Hansen Medical Inc. has received U.S. Food and Drug Administration (FDA) clearance for its smaller diameter Magellan 6Fr Robotic Catheter for peripheral vascular interventions. 

The Magellan 6Fr Robotic Catheter is the latest addition to the growing family of catheters available for use with the Magellan Robotic System, and features several important advances. Specifically, the Magellan 6Fr Robotic Catheter features novel dual-bend technology, enabling independent robotic control of two separate bend sites on a single catheter, compared to the current Magellan 9Fr Robotic Catheter, which is designed as a telescoping device with two, independently controlled robotic catheters. The 6Fr catheter's new design provides for precise robotic navigation and control in a single, smaller diameter 6Fr outer diameter catheter, and enables use of the Magellan Robotic System in smaller vessels in the peripheral vasculature and by physicians who may prefer a smaller diameter vessel insertion site. 

"This is a major development for Hansen Medical and intravascular robotics," said Barry Katzen M.D., founder and medical director of Baptist Cardiac & Vascular Institute (Baptist Hospital of Miami). "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." 

"The Magellan 6Fr Robotic Catheter will enable our physician customers to apply the benefits of robotic precision, control, and procedural predictability to the treatment of many more vascular patients, which is one of the fastest growing service lines in hospitals today," said Peter J. Mariani, CFO of Hansen Medical. "This new catheter demonstrates our commitment to expanding the potential clinical applications of Magellan, providing further support to the compelling return on investment potential associated with a multi-disciplinary Intravascular Robotics program. In addition to enabling a smaller diameter, the Magellan 6Fr Robotic Catheter also features a simplified clinical workflow and was designed for improved manufacturability. I want to congratulate the talented engineering and product development teams at Hansen Medical for this important milestone in our continued development of intravascular robotics technology." 

The company's Magellan Robotic Catheters work with the Magellan Robotic System and are designed to allow improved procedural predictability, control and catheter stability as a physician navigates a patient's peripheral vasculature, and then provide a conduit for manual placement of therapeutic devices for the treatment of vascular disease. The Magellan Robotic System also allows the physician to navigate through the vasculature while seated comfortably at a remote workstation, away from the radiation field, potentially reducing physician radiation exposure and fatigue. Approximately two million peripheral vascular procedures are performed annually in the U.S. and Europe, the majority of which are now potentially addressable with the Magellan Robotic System. 

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

Source: Hansen Medical Inc.