Devices Cardiology Interventional FDA

 News Release - February 7, 2006

Biosense Webster Receives FDA Approvals for Technology to Treat Patients With Heart Rhythm Disease

Products Integrate Biosense Webster Catheters With Stereotaxis Automated Navigation Technology for Treatment of Cardiac Arrhythmias

DIAMOND BAR, Calif., Feb. 7 (HSMN NewsFeed) -- The U.S. Food and Drug Administration (FDA) today approved an innovative combination of technologies that will enhance a doctors' ability to treat patients with abnormal heart rhythms (cardiac arrhythmias). The approvals result in the first and only commercially available products for use during cardiac radiofrequency ablation. Cardiac radiofrequency ablation is a non-surgical procedure during which a catheter delivers energy to damaged heart tissue to restore normal heart rhythms. Cardiac arrhythmias affect millions of people nationwide.

The FDA approvals cover the use of the NaviStar® RMT Steerable Tip Diagnostic/Ablation Catheter and the Celsius® RMT Steerable Tip Diagnostic/Ablation Catheter with the Niobe® Magnetic Navigation System, designed by Stereotaxis, Inc. With these approvals, Biosense Webster now offers the only products that work with the Stereotaxis system to enable electrophysiologists (doctors that treat the heart's electrical system) to steer a catheter remotely, map the electrical activity of the heart, and ablate targeted areas that require treatment.

"This is good news for doctors and patients. By integrating Biosense Webster's catheters with Stereotaxis' Niobe system, we get leading diagnostic and ablation technology combined with an automated mapping and steering system, resulting in greater ability to treat a broad range of patients, including the most complex cases," said Gery F. Tomassoni, MD, Director, Central Baptist Hospital Cardiac Research, Lexington, Kentucky. "This advance offers new options for patients who would have otherwise faced a lifetime of antiarrhythmic medications."

Biosense Webster President Roy Tanaka commented, "Since its inception, Biosense Webster has partnered with the electrophysiology community to set new standards for treating patients with heart rhythm disease. The enhancements to patient care afforded by these FDA approvals are gratifying and represent the next chapter in our product development and partnering strategies that will have benefit to patients and doctors now, and well into the future."

In October 2005, Biosense Webster received FDA clearance for the Carto(TM) RMT Navigation System and NaviStar® RMT Catheter to be integrated with the Niobe® Navigation technology from Stereotaxis. In addition, the company received clearance for the RefStar(TM) RMT Catheter which provides a reliable reference point within the Carto(TM) RMT System to ensure an accurate visual framework for mapping diagnostic procedures.

About Biosense Webster

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'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® Irrigated Tip Catheter and the Lasso® Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

Source: Biosense Webster

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