Hansen Medical, Inc. (Hansen Medical) has received US Food and Drug Administration (FDA) clearance for its next generation Sensei X Robotic Catheter System and it introduced the Artisan Extend Control Catheter. The company has also introduced its Lynx Robotic Ablation Catheter, a small, flexible irrigated ablation catheter for customers in Europe.

According to Hansen Medical, 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 EU within the first half of 2010. The Lynx catheter is not currently available for sale in the US.

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% 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.

The company plans to begin shipping the new Sensei X system in the third quarter of 2009 in the US and the EU. The company will begin shipping the Artisan Extend catheter in the US in the third quarter of 2009 and expects that the Artisan Extend catheter will receive the CE mark in the fourth quarter of 2009. The Lynx robotic ablation catheter will be available in the EU upon receipt of the CE mark, which is expected in the first half of 2010.

Hansen Medical develops, manufactures and sells generation of medical robotics designed for accurate positioning, manipulation and stable control of catheters and catheter-based technologies.