CoHesion Module Approved by the Feds
A cooperative product, the CoHesion 3D Visualization Module, was granted marketing clearance by the U.S. Food and Drug Administration. The new tool is indicated for use during complex electrophysiology (EP) mapping procedures, as described in the news release from Hansen Medical.
The system utilizes a software interface between the EnSite System, an advanced mapping software system from St. Jude Medical and the Sensei Robotic Catheter system from Hansen Medical. These systems allow clinicians the opportunity to navigate a catheter more instinctively during the diagnostic component of procedures for complex cardiac arrhythmias. It is anticipated that availability of this system will optimize catheter placement.
The CoHesion tool incorporates the 3D cardiac chamber model from EnSite, which includes anatomic labeling. This feature is integrated into the main navigation window of the Sensei. These features provide clinicians the means to visualize the catheters while they are in the heart in 3D.
The system was already released to the European Union. Eight different Sensei systems have already been modified to include the new module. Advantages of incorporating the tools together include both visualization and localization of the catheter in 3D. Clinicians have previously only be able to to assess the position of the catheter with 2D visualization, using either ultrasound or fluoroscopy.
The Sensei, computer-based technology for catheters from Hansen Medical, gives clinicians both predictable and stable control of the catheter. One advantage provided to clinicians is the ability to access anatomy that is difficult to reach.
July 3, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Diagnostic, Cardiology