SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

April 14, 2015 09:00 ET

Hansen Medical® Receives CE Mark for Magellan™ 10Fr Robotic Catheter

MOUNTAIN VIEW, CA--(Marketwired - Apr 14, 2015) - Hansen Medical®, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today announced the Company's Magellan™ 10Fr Robotic Catheter has received European Conformity (CE) Marking for use in the peripheral vasculature. Achieving this milestone allows the company to market the Magellan 10Fr Robotic Catheter in Europe and other countries that require the CE Mark.

The Magellan 10Fr Robotic Catheter is the latest addition to the family of robotic catheters used with the Magellan Robotic System. The 10Fr catheter allows for independent, robotic control of the distal tips of two telescoping catheters (an outer Guide and an inner Leader catheter). The Guide catheter has a 10Fr outer diameter, and features the largest inner lumen (7Fr) in the Magellan catheter family, which enables delivery of therapeutic devices through the robotic catheter in a broader range of endovascular procedures. 

"The Magellan 10Fr Robotic Catheter is an important advance for intravascular robotics and the Magellan Robotic System," said Dr. Thomas Nolte, Director of the Vascular Center at the Heart & Vascular Center in Bad Bevensen, Germany. "The larger inner lumen will enable physicians to precisely deliver therapeutic devices through a stable, robotic catheter platform in many more vascular procedures. In particular, many complex endovascular aneurysm repairs and lower extremity arterial revascularizations involve delivery of stents, balloons or other devices requiring a 7Fr catheter inner lumen." 

The Magellan Robotic System is an advanced technology that drives Magellan Robotic Catheters and guide wires during endovascular procedures. Magellan is designed to offer procedural predictability, control, and catheter stability to physicians as they navigate through the blood vessels and deliver therapy. Magellan's remote workstation allows physicians to control robotic catheters and guide wires while seated away from the radiation field, potentially reducing physicians' radiation exposure and procedural fatigue.

"We are excited to begin introduction of the Magellan 10Fr Catheter," said Cary Vance, President and Chief Executive Officer of Hansen Medical. "We are focused on broadening the capabilities and utility of the Magellan Robotic System in the minimally-invasive treatment of vascular disease. With this new catheter, our physician and hospital customers can expand utilization of Magellan, and we believe that many more patients will now be able to benefit from the precision, stability and control offered by the Magellan."

About the Magellan™ Robotic System
Hansen Medical's Magellan Robotic System is intended to be used to facilitate navigation in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan Robotic System is designed to deliver predictability, control and catheter stability to endovascular procedures. Since its commercial introduction in the U.S. and Europe, the Magellan Robotic System has demonstrated its clinical versatility in many cases in a broad variety of peripheral vascular procedure types in centers across the U.S. and Europe. The Magellan Robotic System offers several important features including:

  • Provides predictability, control and catheter stability as a physician navigates a patient's peripheral vasculature and then provides a conduit for manual treatment of vascular disease with standard therapeutic devices.
  • Is designed to enable more predictable procedure times and increased case throughput potentially allowing hospitals to improve utilization within their vascular business line
  • Employs an open architecture designed to allow for the subsequent use of many therapeutic devices on the market today.
  • Is designed to potentially reduce physician radiation exposure and fatigue by allowing the physician to navigate procedures while seated comfortably at a remote workstation away from the radiation field and without wearing heavy lead as required in conventional endovascular procedures. 
  • The Magellan 9Fr and 10Fr Robotic Catheters allow for independent, robotic control of the distal tip of two telescoping catheters (an outer Guide and an inner Leader catheter), as well as robotic manipulation of standard guide wires.
  • The Magellan 6Fr Robotic Catheter allows for independent robotic control of two separate bend sites on a single catheter, as well as robotic manipulation of standard guide wires. This smaller catheter design may be preferred by certain physicians who prefer a smaller diameter vessel access site, or in procedures in smaller vessels. 

About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a global leader in Intravascular Robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company's Magellan™ Robotic System, Magellan Robotic Catheters, and related accessories are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Company's mission is to enable Cardiac Arrhythmia and Endovascular Procedures and to improve patient outcomes through the use of Intravascular Robotics. Additional information can be found at www.hansenmedical.com.

"Hansen Medical," "Hansen Medical (with Heart Design)," and "Heart Design (Logo)" are registered trademarks, and "Magellan" and "Hansen Medical Magellan" are trademarks of Hansen Medical, Inc. in the U.S. and other countries. All other trademarks are the property of their respective owners.