Hansen Medical Announces Successful Completion of Clinical Trial for Sensei Robotic Catheter System
MOUNTAIN VIEW, CA–(MARKET WIRE)–Dec 22, 2006 — Hansen Medical, Inc. (NASDAQ:HNSN – News), a developer of new generation robotic technology for accurate and stable control of catheter movement in 3D during cardiac procedures, announced today the successful completion of a clinical trial and seven-day follow-up using the Sensei(TM) Robotic Catheter System.
The 20-patient prospective trial was an observational study using the Sensei system to guide catheters into the heart for mapping heart anatomy — a critical step in identifying heart tissue that generates abnormal heart rhythms, often requiring treatment. 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 allowed me to very easily place mapping catheters in hard-to-reach anatomical locations within the heart, with enhanced stability during cardiac arrhythmia mapping,” said Wyn Davies, M.D., FRCP, FHRS, consultant cardiologist, St. Mary’s Hospital, London, and principal investigator of the trial. “Therefore, this new technology has the potential to fundamentally change the way electrophysiology procedures are performed worldwide and make it possible for a broader group of physicians to offer these complex procedures.”
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 reduce training time,” said Frederic Moll, M.D., founder and chief executive officer of Hansen Medical. “We are very pleased with the results from the trial and seven-day follow-up. As a result, the company is well poised to not only enhance the speed and ease-of-use of catheter-based procedures in the heart, but may also improve patient 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.
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.