Biosense and Stereotaxis' integrated device for heart catheterization cleared by FDA

By Lisa Kerner

Charlotte, N.C., June 27 - The Food and Drug Administration granted 510(k) marketing clearance to The Carto RMT V8 System from Biosense Webster, Inc. and the Niobe Magnetic Navigation System from Stereotaxis, Inc. which together provide doctors specializing in the heart's electrical system (electrophysiologists) with automated, 3-D mapping and navigation tools for the treatment of arrhythmias.

"The synergies created by these technologies will better enable physicians to treat even the most complex cases," Carlo Pappone, head of arrhythmia and cardiac electrophysiology, Hospital San Raffaele in Italy, said in a news release.

"With ease of automation, the advantages of precise and efficient navigation, and the added benefit of reduced fluoro exposure, these technologies simplify complex procedures."

Based in St. Louis, Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system used in the treatment of coronary artery disease and arrhythmias.

Located in Diamond Bar, Calif., Biosense Webster is a Johnson & Johnson company that provides advanced diagnostic, therapeutic and mapping tools.

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