Healthcare Industry News:  Biosense Webster 

Devices Cardiology FDA

 News Release - August 22, 2006

U.S. Food and Drug Administration Grants Expanded Indication for the NaviStar(R) ThermoCool(R) Catheter for Treatment of Ventricular Tachycardia (Rapid Heart Beat)

DIAMOND BAR, Calif., Aug. 22 (HSMN NewsFeed) -- The U.S. Food and Drug Administration (FDA) has granted an expanded indication to the first automated ablation system supporting an open-loop irrigated catheter. The NaviStarŽ ThermoCoolŽ Catheter is now available for the treatment of adults with specific rapid heartbeats, who have already experienced failure with other treatments such as device or other antiarrythmic drug therapy. These specific rapid heartbeats are scientifically known as Ventricular Tachycardia (VT) that arise following a heart attack. The NaviStarŽ ThermoCoolŽ Catheter is the first FDA-approved catheter to treat both mappable and unmappable VTs.

The expanded indication provides cardiac electrophysiologists (doctors specializing in the treatment of heart rhythm disorders) with an important new treatment option for the estimated 3 million people in the U.S. who live with this potentially dangerous heart rhythm condition. "For patients with Ventricular Tachycardia, the sudden increase in heart rate can be life- threatening," said William Stevenson, MD, Director of Clinical Cardiac Electrophysiology at Brigham and Women's Hospital in Boston, Mass. "There have been no substantial improvements in therapies to prevent VT in recent years. Implantable defibrillators treat VT after it has occurred, and drug therapy is often ineffective. The expanded indication of the NaviStarŽ ThermoCoolŽ Catheter is a major advance in the treatment of Ventricular Tachycardia."

VT is a rapid heart beat that originates in one of the lower chambers (the ventricles) of the heart. Treatment with catheter ablation has been challenging, because locating the sites that need to be ablated can be difficult, particularly when the VT is not hemodynamically tolerated to allow extensive mapping during the arrhythmia. These VTs -- commonly referred to as "unmappable" -- are often associated with sudden death in VT patients. The NaviStarŽ ThermoCoolŽ Catheter combined with the Carto(TM) XP Mapping System facilitates identification of ablation sites during stable sinus rhythm allowing treatment of these unmappable VTs as well as mappable VTs.

The automated ablation system incorporates the NaviStarŽ ThermoCoolŽ Irrigated Tip Catheter and CoolFlow(TM) Pump from Biosense Webster, Inc. with the Stockert 70 RF Generator. The ThermoCoolŽ Irrigated Tip Catheter, working together with this integrated system, reduces char and thrombus formation during ablation.

The benefits of the enhanced ThermoCoolŽ Irrigated Tip Catheter are well recognized among physicians, accounting for the more than 100,000 units that have been sold worldwide since its launch in 1999.

"The expanded indication for the NaviStarŽ ThermoCoolŽ Irrigated Tip Catheter, with its fully integrated ablation system, gives physicians another important option for treating patients with this potentially dangerous condition," said Roy Tanaka, President, Biosense Webster, Inc. "Electrophysiologists have come to rely on Biosense Webster for the ideas that make a difference to their practices and their patients."

The ThermoCoolŽ Catheter is also available to treat atrial flutter, a common rapid heart rhythm that arises in the upper chambers of the heart.

About Biosense Webster, Inc.

Biosense Webster, Inc., a Johnson & Johnson company, pioneered EP 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 ThermoCoolŽ Irrigated Tip Catheter and the LassoŽ Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

Source: Biosense Webster

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