NaviStar ThermoCool Catheter. Image source: Biosense Webster

The FDA has granted marketing approval to Biosense Webster's NaviStar ThermoCool Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (a-fib), when used with compatible 3D electroanatomic mapping systems.

On Nov. 20, 2008, the FDA's Circulatory System Devices Panel unanimously recommended approval of the NaviStar ThermoCool Catheter for a-fib. The NaviStar is the first ablation catheter in the U.S. to be approved for the treatment of this disorder, which affects an estimated 10 million people globally.

The FDA said it based the approval on a clinical study of 167 patients at 19 medical centers in the United States, Brazil, Canada, the Czech Republic and Italy. Data from the study showed the devices to be effective in eliminating symptomatic recurrence of a-fib episodes for one year in approximately 63 percent of treated patients versus 17 percent of the patients in the control group, according to the agency.

As a condition of approval, the agency said that the Diamond Bar, Calif.-based BioSense must establish a physician training program and conduct postmarket studies to collect data on these devices’ long-term safety and effectiveness (including incidence of stroke, mortality, cardiac arrest, major bleeding and pulmonary vein stenosis) and the effect of physicians’ experience in operating the device on procedural safety.

The NaviStar is also approved in the U.S. for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior MI, according to Biosense, a Johnson & Johnson company.