Healthcare Industry News:  Stereotaxis 

Devices Cardiology FDA

 News Release - January 15, 2008

Fully Automated, Irrigated Tip Radiofrequency Ablation System with Remote Navigation Receives FDA Approval

Technology Designed to Improve Doctors' Ability to Create Successful Ablations with Added Control and Versatility

DIAMOND BAR, Calif.--(HSMN NewsFeed)--The first fully automated ablation system supporting an open-loop irrigated catheter using remote navigation with the Niobe® Magnetic Navigation System, designed by Stereotaxis, Inc., and the CARTO® RMT System by Biosense Webster, Inc. has received FDA approval.

Cardiac radiofrequency (RF) 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 system incorporates the NAVISTAR® RMT THERMOCOOL® Irrigated Tip Catheter and the COOLFLOW™ Pump from Biosense Webster, Inc., with the Stockert RF Generator. The catheter incorporates small irrigation holes at the tip to provide cooling during RF ablation. The addition of the Niobe® Magnetic System and the CARTO® RMT System provides electrophysiologists with accurate 3-D mapping, targeting and remote navigation.

“The new NAVISTAR® RMT THERMOCOOL® Irrigated Tip Catheter fully integrated with the Niobe Magnetic Navigation System represents another addition to our versatile portfolio of products for ablation,” said Roy Tanaka, President, Biosense Webster. “Electrophysiologists have come to rely on Biosense Webster for the ideas that make a difference to their practices and their patients. This novel technology speaks to our ability to take customer insight into the R&D lab and come back with innovative solutions that enhance both procedural execution and patient outcomes.”

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 CARTO® XP System, the CARTOSOUND™ 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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Please address inquiries directly to the issuing company.



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