Biosense Webster's Magnetically Steered Irrigated Tip Cardiac Catheter Cleared for Marketing for Treatment of Irregular Heart Rhythms.

NAVISTAR([R]) RMT THERMOCOOL([R]) combines the safety of power-controlled irrigated tip technology with the control of remote magnetic navigation away from fluoroscopy exposure

DIAMOND BAR, Calif. -- Patients in the United States with certain types of arrhythmias, also known as irregular heart rhythms, may now benefit from treatment with an innovative state-of-the art catheter. The U.S. Food and Drug Administration has approved for marketing the NAVISTAR([R]) RMT THERMOCOOL([R]) Catheter, which is designed to maintain safe tip-to-tissue temperatures and gives physicians the safety and convenience of steering the catheter remotely, away from fluoroscopy exposure, during procedures to eliminate abnormal heart rhythms, namely atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults.

The NAVISTAR([R]) RMT THERMOCOOL([R]) Catheter for radiofrequency (RF) ablation is used with the NIOBE([R]) Magnetic Navigation System, which helps steer a catheter remotely and guide ablation to targeted areas that require treatment.

"Today's approval of the NAVISTAR([R]) RMT THERMOCOOL([R]) Catheter provides electrophysiologists with the proven advantages and benefits of an irrigated catheter with the added control of remote magnetic navigation, which is very convenient," said Vivek Reddy, M.D., Director, Cardiac Electrophysiology at the University of Miami (Florida). "This is yet another important advancement in our treatment options for atrial flutter and ventricular tachycardia."

The NAVISTAR([R]) RMT THERMOCOOL([R]) Catheter, manufactured by Biosense Webster, Inc., in combination with the CARTO([R]) RMT System, can be used to create highly accurate three dimensional (3D) electroanatomical maps. Electrophysiologists are able to steer the NAVISTAR([R]) RMT THERMOCOOL([R]) Catheter using the integrated NIOBE([R]) Navigation technology and a miniature location sensor is placed inside each catheter for real-time, high-resolution mapping.

RF ablation procedures are most often performed to treat rapid, irregular heartbeats (cardiac arrhythmias). The procedure consists in guiding the NAVISTAR([R]) RMT THERMOCOOL([R]) Catheter with the NIOBE([R]) Magnetic Navigation System to the area of heart muscle where cells are giving off electrical signals that stimulate the abnormal heart rhythm. An application of energy is then transmitted to those areas to carefully destroy those heart muscle cells that are conducting the extra impulses that caused the irregular heart rhythm.

"As leaders in electrophysiology, we take pride in transforming insightful ideas from the electrophysiology lab into enhanced technologies that improve procedures and make a difference for patients," said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. "We are pleased to officially launch this exciting product to electrophysiologists in the U.S."

Dr. Reddy is compensated for his time as a consultant to Biosense Webster and has received grants and research support from the company.

About Biosense Webster, Inc.

Biosense Webster, Inc., a Johnson & Johnson company, pioneered electrophysiology diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic and mapping tools. As the leader in navigation systems, Biosense Webster, Inc.'s, technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. With proprietary products such as the CARTOMERGE[TM] Image Integration Software Module, the THERMOCOOL([R]) Irrigated Tip Catheter and the LASSO([R]) Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

For more information, please visit www.biosensewebster.com.