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Hansen Medical's Magellan 6Fr Robotic Catheter Granted CE Marking for Use in Peripheral Vasculature

Hansen Medical, Inc., a global leader in intravascular robotics, today announced the Company's Magellan™ 6Fr Robotic Catheter has received European Conformity (CE) Marking for use in the peripheral vasculature. Achieving this milestone allows the Company to market the Magellan 6Fr Robotic Catheter in Europe and other countries that require the CE Mark.

The 6Fr Robotic Catheter's new dual-bend technology enables independent robotic control of two separate bend sites on a single catheter, providing for precise robotic navigation and control. The small 6Fr outer diameter enables use of the Magellan Robotic System in smaller vessels in the peripheral vasculature and broadens use of intravascular robotics technology to physicians who may prefer a smaller diameter vessel insertion site.

"This is a significant milestone in the development of intravascular robotics," said Mo Hamady, M.D., Imperial College London. "Robotic catheters have the potential to provide physicians with enhanced control and navigation, especially in tortuous vessels. With this smaller-diameter robotic catheter, we can now broaden the types of procedures we are able to perform with the Magellan Robotic System. The new 6Fr Robotic Catheter increases the clinical applications to many interventional vascular therapies involving smaller vessels, including cancer treatment, women's health, and lower limb treatment."

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

The Magellan 6Fr Robotic Catheter received FDA 510(k) clearance earlier this year and is commercially available in the U.S.

"The Company is excited to introduce the Magellan 6Fr Robotic Catheter to European physicians and their patients," said Cary Vance, Hansen Medical President and Chief Executive Officer. "With the increased clinical applications from the 6Fr catheter, more physicians can benefit from robotic precision and control in peripheral vascular procedures, and we can further ensure that hospitals investing in a Magellan intravascular robotics program can utilize our systems in the broadest possible way."

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 Robotic Catheter allows 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 guidewires.
  • 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 guidewires. This smaller catheter design may be preferred by certain physicians who prefer a smaller diameter vessel access site, or in procedures in smaller vessels.

Source: http://www.hansenmedical.com/

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