Posted in | Medical Robotics

Modified Rail for Magellan Robotic System Receives FDA 510(k) Clearance

Hansen Medical, Inc., a global leader in intravascular robotics, today announced it has received U.S. Food and Drug Administration 510(k) clearance for a modified rail for the Magellan™ Robotic System, which enables the company to begin commercial introduction of the Magellan™ Transport System.

The Magellan Transport System is designed to move the Magellan robotic arm between procedure rooms. The Company anticipates commercialization of the Magellan Transport System in the third quarter of fiscal 2014.

"With the launch of the Magellan Transport System, we are delivering on our commitment to ensure that all customers are able to utilize our systems in the broadest possible way," said Cary Vance, Hansen Medical President and Chief Executive Officer. "The Magellan Transport System enables hospitals to expand access to more physicians interested in performing robotic endovascular procedures."

The Magellan Transport System will facilitate greater utilization throughout a hospital by enabling the Magellan robotic arm to be shared among different procedure rooms that are equipped to support the robotic system. These capabilities will allow the Magellan Robotic System to be a shared resource, giving multiple physician specialties access in several settings. Hansen Medical clinical support personnel will operate the device during the initial commercialization period.

"The Magellan Transport System provides flexibility and convenience when implementing an intravascular robotics program for both our existing and future customers," said Joe Guido, Hansen Medical Vice President of Marketing and Business Development. "This will enable hospitals to improve room utilization and maximize the return on their investment in Magellan."

Hansen Medical will also be seeking regulatory clearances to market the Magellan Transport System in Europe.

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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