September 16, 2009 – Hansen Medical Inc. today said it received FDA clearance for its next generation Sensei X Robotic Catheter System and it introduced the Artisan Extend Control Catheter.
The company also plans to introduce the Lynx Robotic Ablation Catheter, a small, flexible irrigated ablation catheter, for customers in Europe this fall.
The new Sensei X platform provides physicians with improved electrophysiology (EP) 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 of the 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.”
The company plans to begin shipping the new Sensei X system in the third quarter of 2009 in the U.S. and the European Union. 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 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.
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, Oct. 4-7.
For more information: www.hansenmedical.com.