Boston Atrial Fibrillation Symposium

Hansen Medical, Inc., will showcase its new generation robotic technology for accurate and stable control of catheter movement during cardiac procedures here at the 12th Annual Boston Atrial Fibrillation (AF) Symposium, January 11-13, 2007. The Sensei Robotic Catheter System is designed to guide catheters for mapping heart anatomy during the treatment of patients suffering from abnormal heart rhythms, or arrhythmias.

The company recently announced the successful completion of a 20-patient prospective trial and seven-day follow-up using the Sensei system to guide catheters for mapping heart anatomy, which is a critical step in identifying heart tissue that generates abnormal heart rhythms. Data from the follow-up showed no device-related adverse events, and is being prepared as part of a submission to the U.S. Food & Drug Administration (FDA) in support of a 510(k) currently under review.

Currently, cardiac electrophysiology procedures are performed using a manual technique that 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. As a result, achieving stable contact at every anatomic site within the heart necessary for successful mapping can be difficult. Insufficient contact between the catheter tip and the inside of the heart wall can lead to highly variable and less than optimal procedure outcomes.

To date, 83 cardiac procedures have been performed on patients in Europe using the Sensei Robotic Catheter System. The new technology incorporates fluoroscopic, intracardiac ultrasound, 3D surface map and patient electrocardiogram data into one portable workstation. The workstation can be easily moved among catheter lab suites and does not require costly construction of a specialized room. Hansen Medical anticipates that its proprietary system will enhance the ease-of-use and stability of catheter-based procedures by offering physicians better control over catheter placement, as well as potentially decrease procedure times and radiation exposure.

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