A Medical Device Daily

The FDA has approved Biosense Webster's (Diamond Bar, California) Navistar RMT Thermocool catheter, which is designed to maintain safe tip-to-tissue temperatures and gives physicians the safety and convenience of steering the catheter remotely, away from fluoroscopy exposure, during procedures to eliminate abnormal heart rhythms, namely atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction in adults.

Radio frequency ablation procedures most often are performed to treat rapid, irregular heartbeats (cardiac arrhythmias). The procedure consists in guiding the catheter with the Niobe magnetic navigation system, made by Sterotaxis (St. Louis), to the area of heart muscle where cells are giving off electrical signals that stimulate the abnormal heart rhythm. An application of energy is then transmitted to those areas to carefully destroy those heart muscle cells that are conducting the extra impulses that caused the irregular heart rhythm.

"[The] approval of the Navistar RMT Thermacool catheter provides electrophysiologists with the proven advantages and benefits of an irrigated catheter with the added control of remote magnetic navigation, which is very convenient," said Vivek Reddy, MD, director of cardiac electrophysiology at the University of Miami in Florida. "This is yet another important advancement in our treatment options for atrial flutter and ventricular tachycardia."

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