Biosense Webster announces FDA clearance


Diamond Bar, CA – October 12, 2005 – Biosense Webster, Inc. today announced that the company has received clearance by the U.S. Food and Drug Administration (FDA) for devices that aid electroanatomical mapping. The CARTOTM RMT Navigation System, NAVISTAR® RMT Steerable Tip Diagnostic Catheter, and REFSTARTM RMT Catheter with the QWIKPATCH® External Reference Patch products were all designed to integrate with the Niobe® Magnetic Navigation System designed by Stereotaxis, Inc. The clearance of these Biosense Webster products by the FDA provides electrophysiologists additional tools and maneuvering capabilities when using the Niobe® Magnetic Navigation System to allow doctors to steer a catheter remotely.

Electroanatomical mapping allows you to create a 3D map of the heart showing electrical activity. By developing the 3D map using the Biosense Webster technology, doctors are able to pinpoint the exact timing or voltage of the electrical signal which allows for a more timely diagnosis of the patient's irregular heart beat (arrhythmia).

"This advanced technology from Biosense Webster provides improved capabilities for magnetic maneuvering," said Gery F. Tomassoni, MD, Director, Central Baptist Hospital Cardiac Research, Lexington, Kentucky. "Doctors can now perform high-precision procedures, such as mapping potentially life-threatening arrhythmias, while lowering the risks of radiation exposure."

"We are very pleased with the FDA clearance. Our remote magnetic technology coupled with the Niobe® Navigation System marks the beginning of a whole new era of electrophysiological innovation," said Roy Tanaka, president of Biosense Webster.

The products cleared by the FDA include:

CARTOTM RMT System combines unparalleled accuracy and precision in electroanatomical mapping with a new level of navigational control. The integration of the highly advanced Niobe® Navigation technology will enable electrophysiologists to utilize the full feature set of the previously introduced CARTOTM XP System with the additional flexibility of remote operation.

NAVISTAR® RMT Catheters work with the CARTOTM RMT System to create highly accurate 3D electroanatomical maps. Electrophysiologists will now be able to steer the NAVISTAR® Catheter using the integrated Niobe® Navigation technology while visualizing it within the CARTOTM RMT System map image. A miniature location sensor is placed inside each catheter for real-time, high-resolution mapping.

REFSTARTM RMT Catheters provide a reliable reference point within the CARTOTM RMT System to ensure an accurate visual framework for mapping diagnostic operations.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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