Hansen Medical, Inc. (HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, Monday said it has submitted a 510(k) pre-market notification application with the U.S. Food and Drug Administration on its Vascular Robotic System and Catheter.
The Vascular Robotic System is based upon the leading flexible robotic technology incorporated in the Sensei-X Robotic Catheter System currently sold in the U.S. and Europe, and which has been used in more than 5000 procedures in patients with cardiac arrhythmia.
In the US, the Vascular Robotic System is not available for sale pending clearance of the 510(k) submission, which is currently under review. Meanwhile, in Europe, the System requires CE mark and is not available for sale, nor can it be marketed until the CE mark is received.
by RTT Staff Writer
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