Hansen Medical has submitted a 510(k) pre-market notification application with the US Food and Drug Administration (FDA) on its Vascular Robotic System and Catheter, for use in patients with cardiac arrhythmia.
The Hansen Medical Vascular Robotic System is based upon the flexible robotic technology incorporated in the Sensei-X Robotic Catheter System currently sold in the US and Europe.
The Vascular Robotic System includes a number of key enhancements from the Sensei-X Robotic Catheter System to optimize the new system’s use in vascular anatomy.
The Vascular System allows for 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 flexibility to be compatible with most 6F therapeutic catheters currently in use.
The system is designed to allow for sufficient extension inside the body to better access hard to reach peripheral anatomy.
It preserves the open architecture featured in the Sensei system to allow for the subsequent use with most therapeutic catheters.
In the US, the Vascular Robotic System is not available for sale pending clearance of the 510(k) submission, which is currently under review.
In Europe, the system requires CE mark and is not available for sale, nor can it be marketed until the CE mark is received.