Sensei® X Robotic Catheter System Received FDA Approval on Friday, September 11
On Tuesday, September 15, 2009, physicians at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center performed the first procedure worldwide using the Sensei® X Robotic Catheter System, which received clearance from the U.S. Food & Drug Administration (FDA) on Friday, September 11, 2009. Electrophysiologists at TCAI use the new system to more effectively treat patients with atrial fibrillation, or A Fib—a common heart rhythm disorder that, if left untreated, can lead to stroke.
The new Sensei® X Robotic Catheter System, manufactured by Hansen Medical, Inc., is the next generation flexible robotic platform that integrates advanced levels of 3D catheter control with 3D visualization, a combination that provides accuracy and stability to the physician.
“With this device, we are able to reach deeper into the heart, allowing us to place catheters with greater precision and accuracy,” Rodney P. Horton, M.D., electrophysiologist at TCAI, said. “This advanced navigation allows us to safely and effectively treat patients with A Fib through complex arrhythmia mapping procedures.”
The new Sensei X platform uses the 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. Artisan Extend™ Control Catheter received FDA approval last month.
The new Sensei X system allows doctors to control an electronic “arm” from a work station outside of the electrophysiology (EP) lab, improving their technical capabilities during EP procedures. It also reduces radiation exposure to both patient and physician.
TCAI is one of the world's most comprehensive centers dedicated to the latest treatment advances for correcting A Fib. It is led by Andrea Natale, M.D., F.A.C.C., a world-renowned expert on abnormal heart rhythms such as A Fib. Natale is at the forefront of the advancement of treatment for A Fib, leading numerous clinical trials and participating in the development of new technologies and procedures.
TCAI is a partnership between St. David's HealthCare and the physician group, Texas Cardiac Arrhythmia.