SOURCE: Hansen Medical, Inc.

July 02, 2008 09:00 ET

Hansen Medical Announces FDA Clearance for CoHesion™ Module

New CoHesion Interface Merges 3D Visualization Guidance From St. Jude Medical With 3D Robotic Navigation

MOUNTAIN VIEW, CA--(Marketwire - July 2, 2008) - Hansen Medical, Inc. (NASDAQ: HNSN), a developer of robotic technology for accurate 3D control of catheter movement during cardiac procedures, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the CoHesion™ 3D Visualization Module for use in complex electrophysiology (EP) mapping procedures. This integrated EP solution offers a software interface between the Hansen Medical Sensei™ Robotic Catheter system and the EnSite™ System advanced mapping software from St. Jude Medical, Inc. Hansen Medical's platform solution offers physicians the ability to instinctively navigate a catheter during the diagnostic phase of a complex cardiac arrhythmia procedure. The new CoHesion module imports the EnSite System's 3D cardiac chamber model with anatomic labeling into the Sensei system's main navigation window, allowing physicians to see the location of Hansen Medical's Artisan™ Control Catheters within the heart in 3D.

Earlier this year, the CoHesion module was released in the European Union and there are currently eight European Sensei systems configured with the new module. One location is the University Heart Center at the University Hospital Hamburg-Eppendorf in Germany, where Professor Stephan Willems*, director of Clinical Electrophysiology and his staff are using CoHesion to remotely manipulate catheters during EP procedures.

"We are performing procedures with great confidence utilizing CoHesion and we find it easy to move catheters within the 3D cardiac space," said Professor Stephan Willems. "We are also seeing a large reduction in the amount of time we use fluoroscopy, which is a benefit to both the patient and physician. For example, in some cases we are able to complete the procedure with less than 10 minutes of fluoroscopy time."

The EnSite System offers state of the art technology for localization and visualization of EP catheters in 3D, and the Sensei system offers 3D remote manipulation of catheters with instinctive control. Previously, two dimensional technologies, such as fluoroscopy or ultrasound were used to assist physicians with guiding catheters inside the heart. Combining the Sensei and EnSite System technologies is intended to provide physicians with 3D visualization that is expected to optimize control over placement of the catheter in specific locations.

"This integrated platform solution is another step in our ongoing strategy to expand our offering to electrophysiologists and ensure that Hansen Medical is at the forefront of finding effective clinical solutions to help physicians," said Frederic Moll, M.D., co-founder and CEO of Hansen Medical. "The CoHesion Module expands our product offerings to provide physicians with what we believe to be a comprehensive and easy to-to-use remote navigation system for complex arrhythmia procedures."

St. Jude Medical's EnSite System is an advanced technology for mapping the electrical activity of the heart, and for localizing and visualizing electrophysiology catheters in real-time. The EnSite System creates 3D graphical displays of cardiac anatomy and arrhythmias, and enables catheter navigation without the use of fluoroscopy.

The Sensei system uses computer-based catheter technology to provide stable and predictable control of catheter movement. This innovative technology is designed to provide fine guide catheter control in 3D to enable physicians the ability to access hard-to-reach anatomy, and to maintain stability during interventional procedures. The physician workstation is adaptable to existing EP procedure rooms and can be placed away from the field of direct radiation. The disposable Artisan™ Control Catheter is comprised of inner and outer steerable guide catheters that accommodate indicated percutaneous catheters.

Hansen Medical technology was recognized in March 2008 by Frost & Sullivan, and presented with the consulting company's 2008 Product Innovation Award in the field of U.S. Image-Guided and Robotic-Assisted Surgery Devices.

About Hansen Medical, Inc.

Hansen Medical, Inc., based in Mountain View, Calif., develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. Its first product, the Sensei™ Robotic Catheter system, is a robotic navigation system that enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately and with stability during complex cardiac arrhythmia procedures. The Sensei system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data and was cleared by the U.S. Food and Drug Administration (FDA) in May 2007 for manipulation and control of certain mapping catheters in Electrophysiology (EP) procedures. The safety and effectiveness of the Sensei system for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. In the European Union, the Sensei system is cleared for use during EP procedures, such as guiding catheters in the treatment of atrial fibrillation (AF). Additional information can be found at www.hansenmedical.com.

Forward Looking Statements

This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, beliefs, expectations, objectives and future events. Hansen Medical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements about plans for expanding technologies, beliefs about the future benefits of new products, expectations about the possible results from the use of new products and intentions to expand into new applications. These statements are based on the current estimates and assumptions of management of Hansen Medical as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause actual results to differ materially from those indicated by forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, the risks and uncertainties inherent in the company's business related to: obtaining and maintaining necessary regulatory clearances; potential safety issues regarding the company's products; the scope of potential use of current and future products; competition from other companies; and the company's ability to successfully market and support its products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Hansen Medical's Quarterly Report on Form 10-Q filed with the SEC on May 12, 2008 and the risks discussed in the company's other periodic reports filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The company undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

"Hansen Medical," "Sensei," "Artisan," "CoHesion," as well as the company's "heart design logo" in use by itself or in combination with "Hansen Medical" are trademarks of Hansen Medical, Inc.

EnSite is a trademark of St. Jude Medical.

*Professor Willems is a paid consultant of St. Jude Medical.