FDA clears Hansen Medical's Sensei X Robotic Catheter System

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™ Control Catheter. The company also introduced the Lynx™ 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™ 3D Visualization Module, which integrates the 3D motion control of the Sensei X system with the 3D visualization of the St. Jude Medical EnSite™ 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."