Healthcare Industry News: Intracardiac Ultrasound
News Release - January 11, 2007
Hansen Medical Showcases New Generation Robotic Catheter Technology at Boston Atrial Fibrillation SymposiumCompany Announces Successful Completion of Clinical Trial for Sensei Robotic Catheter System
BOSTON--(HSMN NewsFeed)--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 Annual Boston Atrial Fibrillation (AF) Symposium, January 11-13, 2007. The Sensei(TM) 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.
"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.
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.
About Hansen Medical, Inc.
Hansen Medical, based in Mountain View, Calif., was founded in 2002 to develop products and technology using robotics for the accurate positioning, manipulation and stable control of catheters and catheter-based technologies. The Sensei system is currently under review for FDA clearance to guide catheters for mapping anatomy of the heart. Additional information can be found at www.hansenmedical.com.
This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about our clinical development results and whether the FDA will consider this sufficient and appropriate to support our planned 510(k) clearance. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including potential safety issues; the scope of potential use of our products; the scope and validity of intellectual rights applicable to our products; competition from other companies; our ability to obtain additional financing to support our operations; our ability to successfully launch and market our product; and other risks detailed in the "Risk Factors" section of our Registration Statement on Form S-1. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Source: Hansen Medical
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