Healthcare Industry News:  Intracardiac Ultrasound 

Devices Cardiology Regulatory

 News Release - May 17, 2007

Hansen Medical Secures CE Mark Approval for Sensei Robotic Catheter System and Artisan Control Catheter

Robotic System Aids in Treatment of Patients Suffering From Arrhythmias

MOUNTAIN VIEW, CA--(Healthcare Sales & Marketing Network)--May 17, 2007 -- Hansen Medical, Inc. (NasdaqGM:HNSN ), a developer of new generation robotic technology for accurate and stable control of catheter movement during cardiac procedures, today announced it has obtained CE Mark approval in the European Union (EU) for its Sensei(TM) Robotic Catheter System and Artisan(TM) Control Catheter. CE Mark approval signifies that the Sensei system and Artisan catheter have met the essential requirements of the Medical Devices Directive and enables the company to begin marketing the system for use during electrophysiology (EP) procedures in the EU.

"The Sensei system is a revolutionary robotic catheter navigation system that has the potential to change the way complex EP procedures are performed, and increase the number that are performed worldwide because of its ability to offer physicians greater catheter control and stability," said Wyn Davies, M.D., FRCP, FHRS, consultant cardiologist, St. Mary's Hospital, London. "The new robotic system allows the operator to perform EP procedures in a more consistent fashion, which I believe will lead to the development of a standard approach for complex diseases. As a result, a broader range of physicians in the EU will be able to effectively perform such procedures that previously required the highest levels of training and skill."

Last month, the company announced that it had commenced shipments of two Sensei systems to its European sales distributor. One system has been installed at a customer site in the Czech Republic and the transaction, which was recorded as deferred revenue in the first quarter, will now be recognized as revenue for the second quarter of 2007. The second system is expected to be installed at the customer site within the next several weeks, and will be recognized as revenue upon completion.

"We are extremely pleased to have obtained CE Mark approval for the Sensei system and Artisan control catheter because it will allow more physicians to perform complex interventional catheter-based procedures throughout the EU," said Frederic Moll, M.D., founder and chief executive officer of Hansen Medical. "There exists strong momentum in both the European and worldwide catheter markets for the exquisite control the Sensei system brings to EP procedures, and Hansen Medical is well poised to not only help enhance the speed and safety, but possibly improve the outcomes of less invasive, catheter-based procedures in the heart."

The new robotic catheter navigation 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.

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. 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 the potential for success and timing of sales in Europe of the Sensei System and Artisan Control Catheter. 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 Quarterly Report on Form 10Q for the quarter ended March 31, 2007. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Hansen Medical has pending trademark applications for "Hansen Medical," "Sensei," "Artisan," "Hansen Artisan," as well as the Hansen Medical "heart design" logo.


Source: Hansen Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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