FDA Clears Smaller Robotic Intravascular Robotic Catheter From Hansen Medical

Mountain View, Calif.-based Hansen Medical Inc. has gained U.S. Food and Drug Administration 510(k) clearance for its smaller Magellan 6 Fr robotic catheter for peripheral vascular interventions.

This catheter is the latest addition to the growing family of catheters available for use with the Magellan robotic system, and features several advances. Specifically, the Magellan 6 Fr 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 9 Fr robotic catheter which is designed as a telescoping device with two, independently controlled robotic catheters. The 6 Fr catheter’s new design is meant to provide precise robotic navigation and control in a single, smaller diameter 6 Fr outer diameter catheter, and to enable 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) in Florida. “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 6 Fr 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, chief financial officer 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 6 Fr 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 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 reportedly 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 United States and Europe, the majority of which are now potentially addressable with the Magellan robotic system.

The company aims to begin a limited release of the Magellan 6 Fr 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.

Hansen Medical is concerned with intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies.