FDA approves new diagnostic/ablation catheter for use with magnetic navigation system

February 09, 2006

Diamond Bar, CA - The US Food and Drug Administration has approved the NaviStar RMT diagnostic/ablation steerable-tip catheter (Biosense Webster, Diamond Bar, CA) for use with the Niobe magnetic navigation system (Stereotaxis, St Louis, MO) and the CARTO electroanatomical mapping system (Biosense Webster).

The approval makes the diagnostic/ablation device the first and only commercially available product for use in radiofrequency ablation with magnetically assisted navigation. Together with Niobe, electrophysiologists using the diagnostic/ablation catheter can remotely navigate through the heart, map electrical activity, and ablate damaged tissue for the restoration of normal rhythm. In a press release issued by Biosense Webster, the company notes that the NaviStar catheter and magnetic navigation system have been used in more than 100 procedures in the laboratory of Dr Carlo Pappone (San Raffaele University Hospital, Milan, Italy).

As previously reported by heart wire , the magnetic navigation system consists of two magnets, external to the patient, that create a magnetic field with sufficient force to steer magnetically tipped catheters and guidewires through the vasculature. Navigation is achieved by changes in the magnetic field to deflect the interventional device. The system has previously been shown to be successful in various cardiac electrophysiology procedures, including mapping, pacing, and ablation.

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