Hansen Medical has gotten FDA clearance for commercialization of its Sensei Robotic Catheter System and Artisan Control Catheter to facilitate manipulation, positioning and control of mapping catheters during electrophysiology (EP) procedures.
The clearance allows physicians to use Hansen Medical's first generation robotic platform to more easily place mapping catheters in hard-to-reach anatomical locations within the heart and maintain catheter stability during the diagnostic phase of complex cardiac arrhythmia treatment. Physicians who have used the product for EP procedures say the Sensei system has the potential to change the way cardiac procedures are performed to a more standard approach for complex diseases.
"By offering physicians the freedom to extend their reach into areas of the heart through a robotically controlled catheter that offers instinctive and deliberate catheter guidance, we believe we can ultimately help physicians to better perform complex catheter procedures and contribute to the successful diagnosis of life threatening cardiac diseases," said Frederic Moll, MD, founder and chief executive officer of Hansen Medical.
Currently, cardiac mapping procedures performed as part of the treatment of patients suffering from abnormal heart rhythms are done using a manual technique. The technique requires physicians to perform a series of complex manipulations at one end of the catheter with inadequate assurance that the tip of the catheter will respond as desired while inside a patient's heart. Achieving stable contact at anatomic sites within the heart, which is essential for successful mapping procedures, can be difficult.
The new robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. The two main components that comprise the system are the Artisan control catheter and an ergonomically designed, remotely placed workstation where the physician is seated throughout each procedure. In addition to lessening operator fatigue, the remote workstation creates a virtual shield for physicians against harmful radiation.