Healthcare Industry News:   Biosense Webster 

Devices Cardiology

 News Release - June 27, 2006

U.S. Food and Drug Administration Clears for Marketing Integrated Electroanatomical Navigation System for Diagnosis and Treatment of Abnormal Heart Rhythms

Integration Between New Carto(TM) RMT V8 System and Niobe(R) Offers Precision and Confidence for Physicians Addressing Heart Rhythm Disease

DIAMOND BAR, Calif., June 27 (HSMN NewsFeed) -- Millions of people suffering from cardiac arrhythmias, also known as abnormal heart rhythms, can look forward to advanced care with another new offering from medical device maker, Biosense Webster, Inc. The U.S. Food and Drug Administration (FDA) today cleared for marketing under a 510K application an innovative technology designed to help physicians diagnose and plan treatment for patients with this condition.

The Carto(TM) RMT V8 System from Biosense Webster, Inc. and the Niobe® Magnetic Navigation System from Stereotaxis, Inc. provide electrophysiologists (doctors specializing in the heart's electrical system) with automated, cutting-edge, 3-D mapping and navigation tools, and a magnetic steering platform.

Among the many enhanced offerings of the system integration are real-time feedback in guiding the catheter to the target, as well as simultaneous display of the NaviStar® RMT Catheter on Carto(TM) RMT System and Niobe® Screens and bi-directional communication between the two technologies. The new system and catheter provide greater efficiency and better signal resolution, reduced redundancy in data entry and increased reproducibility through automation.

"The synergies created by these technologies will better enable physicians to treat even the most complex cases," said Carlo Pappone, M.D., Ph.D., head of Arrhythmia and Cardiac Electrophysiology, Hospital San Raffaele in Milan, Italy. "With ease of automation, the advantages of precise and efficient navigation, and the added benefit of reduced fluoro exposure, these technologies simplify complex procedures."

The FDA clearance continues to cover the use of the NaviStar® RMT Diagnostic/Ablation Steerable Tip Catheter with the Niobe® System. The NaviStar® RMT Catheter is the only catheter that interfaces with the Carto(TM) RMT Navigation System in the Niobe® environment.

Biosense Webster, Inc., a leader in the development of advanced diagnostic, therapeutic and mapping tools for electrophysiologists, is the only company to offer products integrated with the Stereotaxis system, which enables electrophysiologists to steer a catheter remotely, map the electrical activity of the heart and ablate targeted areas with potentially less trauma due to the soft, flexible catheter.

"Since its initial introduction, this integrated system has been improving procedures around the world," said Roy Tanaka, President, Biosense Webster. "By continuing to innovate and advance our technology in partnership with the medical community, we strive to continue fulfilling our commitment to doctors and patients. With each FDA clearance, we get one step closer to realizing that goal of advancing patient care."

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S. and Europe, and Canada.

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 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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