New Steerable Catheter for Treatment of Cardiac Arrhythmias Gains FDA Clearance

 

February 27, 2009

February 27, 2009 – The Biosense Webster NAVISTAR RMT THERMOCOOL Catheter, a magnetically steered irrigated tip cardiac catheter for treatment of irregular heart rhythms, has received FDA clearance.

The new catheter 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 (VT) due to prior myocardial infarction (MI) in adults.

The NAVISTAR RMT THERMOCOOL Catheter for radiofrequency (RF) ablation is used with the NIOBE Magnetic Navigation System, which helps steer a catheter remotely and guide ablation to targeted areas that require treatment.

“Today’s approval of the NAVISTAR RMT THERMOCOOL 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, M.D., director, Cardiac Electrophysiology at the University of Miami. “This is yet another important advancement in our treatment options for atrial flutter and ventricular tachycardia.”

When used in combination with the CARTO RMT System, the NAVISTAR RMT THERMOCOOL Catheter can reportedly be used to create highly accurate 3D electroanatomical maps. Electrophysiologists are able to steer the NAVISTAR RMT THERMOCOOL Catheter using the integrated NIOBE Navigation technology and a miniature location sensor is placed inside each catheter for real-time, high-resolution mapping. They are able to navigate 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.

Dr. Reddy is compensated for his time as a consultant to Biosense Webster and has received grants and research support from the company.

For more information: www.biosensewebster.com.