Magnetically Steered Irrigated Tip Cardiac Catheter for Treatment of Irregular Heart Rhythms Now Available Throughout the European Union

NAVISTAR® RMT THERMOCOOL® combines the safety of power-controlled irrigated tip technology with the control of remote magnetic navigation away from fluoroscopy exposure

Patients in the European Union (EU) with Atrial Fibrillation and other arrhythmias, also known as irregular heart rhythms, may now benefit from treatment with an innovative state-of-the art catheter. The NaviStar® RMT ThermoCool® 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.

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.

The NaviStar® RMT ThermoCool® Catheter, manufactured by Biosense Webster, Inc., in combination with the Carto® RMT System can 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.

“Remote magnetic navigation for Atrial Fibrillation ablation is feasible with a short learning curve,” said Carlo Pappone, MD, PhD, FACC, Director, Department of Arrhythmology, San Raffaele University Hospital, Milan, Italy. “Combined with the proven technology of open irrigation this is an essential tool, especially for complex ablations. As a physician, I am pleased that the product is now widely available.”

The British Standards Institution approved the NaviStar® RMT ThermoCool® Catheter for marketing in August 2008. Earlier this year Biosense Webster had withdrawn the catheter after an external evaluation of the product at nine sites within the EU and Canada. At that time, the company determined that the catheter was performing in a manner inconsistent with the product’s specifications. The inconsistencies have now been rectified, the external evaluation has been completed and the product is available throughout the EU.

RF ablation procedures are most often used to treat rapid, irregular heartbeats (cardiac arrhythmias). The procedure is performed by a doctor guiding the NaviStar® RMT ThermoCool® Catheter with the Niobe® Magnetic Navigation System 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.

“As leaders in electrophysiology, we take pride in transforming insightful ideas from the electrophysiology lab into enhanced technologies that improve procedures and make a difference for patients,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. “We are pleased to officially launch this exciting product to electrophysiologists in the EU.”

Dr. Pappone is compensated for his services as a consultant to the Company.