Hansen Medical, a leading developer of robotic technology for precise three-dimensional catheter movement control and flexible robotics, has revealed that it has put forward a pre-market notification application for its Vascular Robotic System and Catheter to the U.S. Food and Drug Administration (FDA).
This system is founded on the flexible robotic technology, which has been included in the Sensei-X Robotic Catheter System, which has been used for more than 5000 procedures in patients suffering from Cardiac arrhythmia in Europe and in the US.
According to Bruce Barclay, who is the CEO and President of Hansen Medical, this pioneering development was achieved due to the immense hard work put in by the entire R&D team along with other regulatory and clinical teams and also the numerous physicians who have offered their support. After the previous year’s successful Man Clinical studies and this submission, the company wanted to commercialize the Vascular Robotic System and this submission was an important step towards providing flexible robotics to a huge and upwardly growing vascular market.
This system incorporates several key enhancements when compared to the Sensei-X system to be of use in Vascular anatomy procedures. It permits total individual control of the distal tips of the inner leader catheter and the outer sheath, along with manipulation of standard guide wires by the robot. Moreover, the catheter would be offered in varied lengths with high flexibility and a low profile so that it could be compatible with the different 6F therapeutic catheters, which are used in today’s scenario. The system also allows for ample extension within the body to gain better access to the peripheral anatomy. Sensei system’s open architecture is also included in this system so that the current catheters available in the market could be used. In the year 2010, the company had undertaken a First in Man Clinical study in the European region, when 20 endovascular procedures had been successfully performed with the help of an older version of the Vascular Robotic System, proving that this system could help the physicians to safely and efficiently handle peripheral vascular diseases without exposing both themselves and their patients to excessive radiation.
The growth of the vascular market is driven basically by the prevailing obesity and diabetes and by an aging population. Every year almost two million vascular procedures are being carried out, of which the robotic systems could manage one third to half of the procedures being carried out.