The FDA has given Hansen Medical (Mountain View, CA) the green light to bring the Magellan Robotic System domestically for peripheral vascular interventional procedures. It received European approval about a year ago and is already being used by clinicians.
The Magellan allows surgeons to remote control the distal tip of a catheter and a sheath from a workstation, offering potentially greater precision to surgeons and better outcomes with shorter procedure times for patients.
From the announcement:
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 Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The System has the potential to provide 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.
Press release: Hansen Medical Receives FDA 510(k) Clearance for Its Magellan(TM) Robotic System for Peripheral Vascular Interventions…
Flashbacks: World’s First Clinical Use of Magellan Robotic System in Peripheral Vascular Disease; Magellan Robotic System for Vascular Interventions Receives CE Mark
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