FDA Clears Hansen Medical's Magellan Robotic System for Peripheral Vascular Interventions

June 4, 2012—Hansen Medical, Inc. (Mountain View, CA) announced that it has received 510(k) clearance from the US Food and Drug Administration for its Magellan robotic system, including the catheter and accessories. The company will present the Magellan system at the Society for Vascular Surgery's 66th Vascular Annual Meeting on June 7–9, 2012, in National Harbor, Maryland.

In a press release, the company advised that it would immediately commence commercialization at selected centers in the United States, with a full launch expected later in the year. The Magellan system received CE Mark approval last year and was launched in the European Union. The system has been approved in Australia and is pending approval in Canada.

According to Hansen Medical, the Magellan robotic system is intended to facilitate navigation to anatomic targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The system is designed to allow interventionists to perform fast and predictable procedures while seated comfortably in a remote workstation away from the radiation source in order to reduce radiation exposure and physician fatigue.

Hansen Medical stated that the Magellan robotic system is based on the flexible robotic technology incorporated in its Sensei X robotic catheter system, which is commercially available in the United States and Europe. The Magellan system includes enhancements such as solid catheter stability for placement of therapeutic devices. Additional design enhancements outlined in the company's press release enable the following: predictable procedure times; increased case throughput; independent, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter; robotic manipulation of standard guidewires; and sufficient extension inside the body to access hard to reach peripheral anatomy. The Magellan system preserves the open architecture featured in the Sensei X system to allow for the subsequent use of many commercially available 6-F therapeutic devices.

Alan Lumsden, MD, serves as Chair of Hansen Medical's United States scientific advisory board. Dr. Lumsden, who is Chair of the Department of Cardiovascular Surgery and Medical Director of Methodist DeBakey Heart and Vascular Center in Houston, Texas, commented on the Magellan system in the company's press release. He stated, “The Magellan robotic system is a significant technological advancement that may offer important clinical benefits for physicians performing peripheral interventions. The system provides physicians with independent robotic control of both catheter tips to navigate efficiently through a variety of anatomies and lesions. Our in vitro and in vivo animal studies indicate that using this platform has the potential to increase efficiencies in the interventional lab by shortening procedure times and allowing more predictable interventions. Ultimately, we believe this system may facilitate alternative patient treatment options by enabling robotic endovascular interventions.”