Hansen Medical Showcases New Generation Robotic Catheter Technology at Boston Atrial...

Company Announces Successful Completion of Clinical Trial for Sensei Robotic Catheter System

BOSTON -- Hansen Medical, Inc., (Nasdaq:HNSN) will showcase its new generation robotic technology for accurate and stable control of catheter movement during cardiac procedures here at the 12th

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.

"The new robotic catheter system has the potential to fundamentally change the way electrophysiology procedures are performed worldwide and make it possible for a broader group of physicians to perform complex cardiac procedures such as cardiac arrhythmia mapping," said Wyn Davies, M.D., FRCP, FHRS, consultant cardiologist, St. Mary's Hospital, London, and principal investigator of the clinical trial.

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.

"There is a medical need for broader use of catheter-based procedures for diseases where catheters are rarely used today, and we believe our robotic platform will enable more physicians to perform complex interventional procedures through greater ease of use, and possibly improve patient outcomes," said Frederic Moll, M.D., founder and chief executive officer of Hansen Medical.