FDA clears Biosense magnetic, irrigated catheter for radiofrequency ablation
The FDA has approved Biosense Webster's Navistar RMT ThermoCool catheter for use in operations to eliminate abnormal heart rhythms, namely atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior MI in adults.

The Navistar catheter for radiofrequency ablation, designed to maintain tip-to-tissue temperatures, is used with Stereotaxis' Niobe Magnetic Navigation System, which helps steer a catheter remotely and guide ablation to targeted areas that require treatment, the Diamond Bar, Calif.-based company said.

"The magnetic irrigated catheter's approval is the tipping point for Stereotaxis technology," said Mike Kaminski, Stereotaxis' president and CEO.  "Together, with the Remote Navigation System and our recently introduced software platform, Navigant 3.0, with the QuikCAS, the magnetic irrigated catheter represents a quantum leap forward for remote cardiovascular procedures and has demonstrated the potential to establish a new standard of care for treating cardiac arrhythmias in all chambers of the heart."

The Navistar catheter, in combination with the Carto RMT system, can be used to create 3D electroanatomical maps. Electrophysiologists are able to steer the Navistar catheter using the integrated Niobe Navigation technology and a miniature location sensor is placed inside each catheter for real-time, high-resolution mapping, according to Biosense, a Johnson & Johnson company.