Healthcare Industry News:  Robotic Catheter 

Devices Cardiology FDA

 News Release - September 15, 2009

Hansen Medical Unveils Next Generation Robotic Catheter System and Two New Catheters Offering Advanced Navigation Within the Heart

Robotic Irrigated Ablation Catheter for European Union to Offer Stability During Treatment of Atrial Fibrillation

MOUNTAIN VIEW, CA., Sept. 15 - (HSMN NewsFeed) - Furthering the medical robotic frontier in electrophysiology (EP), Hansen Medical, Inc. (NASDAQ:HNSN ) today announced it has received U.S. Food & Drug Administration (FDA) clearance for its next generation Sensei X Robotic Catheter System and it introduced the Artisan Extend(TM) Control Catheter. The company also introduced the Lynx(TM) Robotic Ablation Catheter, a small, flexible irrigated ablation catheter for customers in Europe.

The new Sensei X platform provides physicians with improved procedural planning and workflow, and enhancements in catheter control within the heart during EP procedures. 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 new Lynx robotic ablation catheter, which the company plans to launch in the European market, 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 atrial fibrillation (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 not currently available for sale in the U.S.

"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."

The new 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 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.

The Sensei X platform also supports Hansen Medical's CoHesion(TM) 3D Visualization Module, which integrates the 3D motion control of the Sensei X system with the 3D visualization of the St. Jude Medical EnSite(TM) system. Two features of the Sensei X system designed to improve procedural planning and workflow include Workspace Visualization, an enhancement that allows physicians to see the catheter's reach on a 3D map prior to navigation, and EndoView, a feature that allows physicians to quickly change the orientation to a standard endoscopic view.

"During evaluation of the Sensei X system, we were able to navigate and control the catheter in 3D with greater stability and enhanced responsiveness, which improved our ability to perform complex arrhythmia mapping procedures safely and successfully," said Rahul N. Doshi, M.D., Director, Arrhythmia Services and Chair, Cardiothoracic, St. Jude Medical Center, Fullerton, Calif.

According to Amin Al-Ahmad, M.D., Assistant Professor of Cardiology, Stanford University Medical Center, who also evaluated the Artisan Extend catheter, "The improved flexibility and bend radius with the Artisan Extend catheter allows access to the right inferior pulmonary vein and other cardiac targets that are typically harder to reach when mapping with manual technique. In addition, the set up for the new catheter is simplified, so our procedure time will be reduced."

"Our goal was to develop the next generation robotic platform for EP that is a step towards addressing many of the clinical needs of electrophysiologists and extends the procedural capabilities of Robotic Catheter control during EP procedures," said Frederic Moll, M.D., president and CEO, Hansen Medical. "The positive feedback to the Sensei X system and the two new catheters demonstrates the potential of this new platform to continue to increase the adoption and utilization of robotics in EP procedures. Because EP procedures are expected to grow by double digit percentages annually until 2012, the new Sensei X platform is an ideal choice for hospitals to improve their EP programs."

The company plans to begin shipping the new Sensei X system in the third quarter of 2009 in the U.S. and the E.U. The company will begin shipping the Artisan Extend catheter in the U.S. in the third quarter of 2009 and expects that the Artisan Extend catheter will receive the C.E. mark in the fourth quarter of 2009. 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 Lynx robotic ablation catheter will be showcased for the first time at Venice Arrhythmias 2009, a biannual international workshop on cardiac arrhythmias held in Venice, Italy, October 4-7.

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

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.

EnSite is a trademark of St. Jude Medical.

Source: Hansen Medical

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