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Hansen Medical Submits 510(k) Application with FDA for Vascular Robotics

Hansen Medical, Inc. has submitted a 510 (k) pre-market notification application with the United States Food and Drug Administration for its Vascular Robotics System and Catheter. The company is a global leader in flexible robotics and develops robotic technology for accurate 3D control of catheter movement.

Bruce Barclay, President and CEO of Hansen Medical said that the Hansen Medical 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 5,000 procedures in patients with cardiac arrhythmia.

He added that delivering on this important milestone in the development of the Vascular Robotic System is a tribute to the hard work and success of the entire R&D, clinical and regulatory teams, as well as the multiple physicians that have helped support these development efforts. He said that the submission is a significant step toward delivering flexible robotics to the large and growing vascular market.

The Vascular Robotic System is not available in the United States for sale pending clearance of the 510(k) submission, which is currently under review. In Europe, the System requires the CE mark and is also not available for sale, nor can it be marketed until the CE mark is received.

The Vascular Robotic System has many enhancements over the Sensei-X Robotic Catheter System. The Vascular System allows complete, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter, as well as robotic manipulation of standard guide wires. Further, the catheter is expected to be available in multiple lengths and has a low profile with significant flexibility to be compatible with most 6F therapeutic catheters currently used today.

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