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 approval results in the first and only commercially available products for use during cardiac radiofrequency ablation with the Niobe Magnetic Navigation System, designed by Stereotaxis, Inc. and the CARTO RMT System from Biosense Webster, Inc. 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 approval covers the use of the NAVISTAR RMT Diagnostic/Ablation Steerable Tip Catheter with the Niobe System. Biosense Webster 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 technology has been used in Europe with extensive experience at San Raffaele University Hospital in Milan, Italy. "Our center has performed over 100 procedures using the combined technology of the NAVISTAR RMT Catheter and the Niobe System," said Carlo Pappone, MD, PhD, FACC, Director of the Arrhythmology Department. "It is a true breakthrough technology as one can, for the first time, perform the procedure from a remote location, such as the control room."
Biosense Webster President Roy Tanaka commented, "Since its inception, Biosense Webster has partnered with the electrophysiology community to set new standards for developing innovating products and 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 that will benefit patients and do
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Contact: Lorie Fiber
lorie.fiber@edelman.com
323-202-1046
Edelman Public Relations
9-Feb-2006
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