Medical robotics manufacturer Hansen Medical, Inc. on Thursday announced that it has received U.S. Food & Drug Administration clearance for its next-generation Sensei X Robotic Catheter System.

 

Additionally, the company has introduced two new products based on the Sensei X system: The “Artisan Extend Control Catheter” and “Lynx Robotic Ablation” catheter.

 

Mountain View, Calif.-based Hansen said its new Sensei X platform provides physicians with improved procedural planning and workflow, and enhancements in catheter control within the heart during electrophysiology procedures.  

 

“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 Dr. Frederic Moll, president and CEO of Hansen Medical, in a press statement. “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 first of the two new products -- the Lynx robotic ablation catheter -- is designed for the treatment of atrial fibrillation and other electrophysiology disorders. Set to launch in Europe in the coming months, the Lynx is supported by the Sensei X platform and is equipped with navigation capability of the Artisan Extend catheter, but in a smaller and more flexible integrated profile.

 

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 thinner and safe and its ablations were consistent with my prior experience with other irrigated ablation devices,” said Josef Kautzner, a physician and head of the Department of Cardiology at the Institute for Clinical and Experimental Medicine in 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 Artisan Extend control catheter is also supported by Sensei X system, Hansen’s next-generation flexible robotic platform that integrates advanced levels of 3D catheter control with 3D visualization. As such, the Artisan offers more than 20 percent improvement in both bend and reach than existing catheters, the company said. As a result, physicians can now place catheters deliberately and accurately within the heart.

 

“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,” said Dr. Amin Al-Ahmad, assistant professor of cardiology for Stanford University Medical Center, in a press statement. “In addition, the set up for the new catheter is simplified, so our procedure time will be reduced.”

 

Hansen said it plans to begin shipping the new Sensei X system in the third quarter of 2009 in the United States and Europe.