Hansen Medical, Inc., a developer of robotic technology for accurate 3D control of catheter movement, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Magellan Robotic System, including the catheter and accessories. The Company will commence commercialization at selected centers in the U.S. immediately, with a full launch expected later in the year. The product will be presented at the 66th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, Maryland from June 7-9.
The global vascular market is large and expanding rapidly, driven by an aging population, the prevalence of diabetes and obesity, and an increase in disease awareness. Of the more than 3 million vascular procedures done worldwide each year, approximately one-third to one-half of them could be addressed using the Magellan Robotic System.
The Magellan Robotic System delivers simultaneous distal tip control of a catheter and a sheath, from a centralized, remote workstation. This technology has the potential to reduce vessel trauma during navigation through a variety of anatomies and lesions compared with manual technique and is also designed to provide a robotically stabilized conduit for the placement and delivery of therapeutic devices
Thus the system provides vascular surgeons and other interventionalists the ability to perform fast and predictable procedures, while allowing the physician to be seated comfortably away from the radiation source, which may reduce radiation exposure and physician fatigue.
“Today’s announcement marks one of the most significant milestones in the Company’s history,” said Hansen Medical President and CEO Bruce Barclay. “Not only does the Magellan System have the potential to be a significant growth driver for Hansen, it also represents a fundamental step forward in the transformation of vascular intervention using intravascular robotics.”
“We are excited about the initial interest a number of key U.S. hospitals have shown in the Magellan System and intend to focus our near-term commercialization strategy on partnering with a select group of esteemed physicians who are both influential and early adopters of new technologies in the industry,” said Barclay.
The Magellan System received a CE Mark in the European Union last year, and the Company has already commenced a commercial launch in that region. In addition, the System has been approved in Australia, and is pending approval in Canada.