Actualizado 30/11/2011 10:02
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Hansen Medical Announces Worldwide Survey of AF Ablation with Robotic Navigation Presented at American Heart Association

Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company's Sensei(R) X Robotic Catheter System and Artisan(R) Control Catheter were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the United States, the Sensei(R) System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei(R) X System and Artisan(R) Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established. In the European Union, the Sensei(R) X System and Artisan(R) Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx(R) Robotic Ablation Catheter is cleared for the treatment of AF. The Company's Magellan(TM) Robotic System, NorthStar(TM) Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone conformity assessment and CE marking and are commercially available in the European Union.

In the U.S., the Magellan(TM) Robotic System, the NorthStar(TM) Robotic Catheter and accessories are the subject of a pending 510(k) with the FDA and are not commercially available. Additional information can be found at http://www.hansenmedical.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "potential," "believes," goal," "estimate," and similar words. 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 and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such forward-looking statements include, but are not limited to, statements about the expected timing of regulatory submissions, approvals, clearances, and commercialization of our robotic systems and catheters, the market potential for our products, the expected sales and utilization levels for our products, and the potential benefits of our products in the treatment of patients. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include, among others: potential safety and regulatory issues that could delay, suspend or terminate clinical studies, regulatory approvals or sales; challenges in designing, engineering and manufacturing systems and catheters to function as intended; uncertain timelines, costs and results of clinical trials and the development of new products; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; and the effect of credit, financial and economic conditions on capital spending by our potential customers. These and other risks are described in greater detail under the heading "Risk Factors" contained in our Quarterly Report on Form 10-Q filed with the SEC on November 11, 2011 and our other periodic SEC filings. 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 (Logo), Hansen Medical (with Heart Design), Sensei, Artisan, Lynx and IntelliSense are registered trademarks, and Magellan, NorthStar are trademarks of Hansen Medical, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

CONTACT: Investor Contacts: Dr. Roland Peplinski, General Manager, EMEA,AP & Canada, Hansen Medical, UK Ltd, +44-20-7393-1905. Toby Minton,+44-(0)7921762293

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