SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

October 05, 2009 01:00 ET

Hansen Medical Showcases New Robotic Irrigated Ablation Catheter at Venice Arrhythmias 2009

Company Also Highlights New Sensei X System and Artisan Extend Control Catheter Offering Advanced Navigation Within the Heart

VENICE, ITALY--(Marketwire - October 5, 2009) - Hansen Medical, Inc. (NASDAQ: HNSN) will showcase its new Lynx™ Robotic Ablation Catheter for the first time at Venice Arrhythmias 2009, the 11th International Workshop on Cardiac Arrhythmias, Oct. 4-7, in Venice, Italy. The Lynx catheter is a small, flexible irrigated ablation catheter for customers in Europe to offer stability during the treatment of Atrial Fibrillation (AF). The company will also show its Sensei® X Robotic Catheter System and the Artisan Extend™ Control Catheter at the conference, which were introduced on September 15, 2009.

The new Lynx robotic ablation catheter is supported by the Sensei X platform and leverages the navigation capability of the Artisan Extend catheter, but in a smaller and more flexible integrated profile for the treatment of AF and other electrophysiology disorders. Offering a seven French irrigated ablation tip with a standard sized sheath, the new Lynx catheter has six degrees of freedom that facilitates placement in difficult to reach anatomic locations. Pending CE Mark approval, the Lynx catheter is expected to be available in the European Union within the first half of 2010.

"The Lynx catheter is thinner and safe and its ablations were consistent with my prior experience with other irrigated ablation devices," said Josef Kautzner, M.D., Ph.D., FESC, Head, Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague. "In addition, the learning curve for the new catheter may be shorter, which I believe will help a broader group of physicians to perform complex ablation procedures for the treatment of AF with greater effectiveness."

"We believe that the launch of our Lynx catheter will create even more demand for Hansen Medical's latest medical robotic product offerings as the Lynx catheter and Sensei X platform will enable clinicians to extend procedural capabilities and improve their EP programs," said Frederic Moll, M.D., president and CEO, Hansen Medical.

The Sensei X system is the next generation flexible robotic platform that integrates advanced levels of 3D catheter control with 3D visualization, a synergistic technology combination that provides enhanced accuracy and stability to the physician. The Sensei X platform supports the new Artisan Extend control catheter, which increases the reachability and navigation properties of the existing Artisan catheter by offering more than 20 percent improvement in both bend and reach. As a result, physicians have the ability to place catheters deliberately and accurately within the heart. In addition, the Artisan Extend catheter offers improvements in setup and workflow, designed to improve usability and reduce procedure time.

In addition, the Sensei X platform provides physicians with improved procedural planning and workflow, and enhancements in catheter control. During clinical evaluations, physicians indicated that the Sensei X system and the Artisan Extend control catheter improved their technical capabilities during EP procedures, while continuing to reduce radiation exposure to both patient and physician.

The Lynx robotic ablation catheter will be available in the E.U. upon receipt of the C.E. mark, which is expected in the first half of 2010. The company began shipping the new Sensei X system in the third quarter of 2009 in the U.S. and the E.U. The company also began shipping the Artisan Extend catheter in the U.S. in the third quarter of 2009 and it expects that the Artisan Extend catheter will receive the C.E. mark in the fourth quarter of 2009.

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, 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 atrial fibrillation (AF), have not been established. The Sensei system is CE Marked for use during EP procedures, such as guiding catheters in the treatment of 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 expectations, projections, estimates, goals, plans, objectives and future events. We intend 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 the company's expectations for regulatory clearances, the timing of initial product shipments, benefits of newly introduced products and projected numbers of procedures in future periods. These statements are based on the current estimates and assumptions of our management 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, risks and uncertainties inherent in our business, including potential safety and regulatory issues that could delay approvals or slow or suspend our sales, our ability to effectively sell, service and support our products, the rate of adoption of our systems and the rate of use of our catheters at customers that have purchased our systems, the scope and validity of intellectual property rights applicable to our products and competition from other companies. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Quarterly Report on Form 10-Q filed with the SEC on August 6, 2009. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. 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, Heart Design, Hansen Medical & Heart Design, Sensei and IntelliSense are registered trademarks, and Artisan, Artisan Extend, Lynx, CoHesion, Fine Force Technology and Instinctive Motion are trademarks of Hansen Medical, Inc., in the United States and other countries.

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