A Medical Device Daily
Johnson & Johnson (New Brunswick, New Jersey) won U.S. approval for two devices to treat a type of abnormal heart beat, known as atrial fibrillation (AF), the FDA said on Friday.
The NaviStar ThermoCool and the EZ Steer ThermoCool Nav, produced by the company's Biosense Webster (Diamond Bar, California) unit, are the first ablation catheters approved to treat AF, a statement by the FDA said.
The FDA has granted marketing approval to the NaviStar ThermoCool Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal AF, when used with compatible three-dimensional electroanatomic mapping systems.
The ThermoCool is a saline irrigated radio frequency ablation catheter that can be used to create small, strategically placed scars in heart tissue to block irregular electrical waves that cause atrial fibrillation. The FDA previously approved other ablation catheters to treat arrhythmias such as atrial flutter and ventricular tachyarrhythmia, but not AF.
"[This] announcement is a milestone for electrophysiologists, physicians who specialize in heart rhythm disorders, and their patients throughout the U.S.," said Marcia Yaross, PhD, VP, Clinical, Regulatory and Health Policy, Biosense Webster. "This landmark decision by the FDA recognizes the safety and effectiveness of NaviStar ThermoCool Catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy."
"This approval provides physicians with another option for treating this common and potentially debilitating condition," said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health.
As a condition of approval, BioSense Webster 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.
FDA noted that AF is usually treated with drugs, and in certain severe cases, with open heart surgery. Catheter ablation should be used only after drug treatment has failed to adequately control the symptoms of the condition.
The FDA based this approval on a clinical study of 167 patients at 19 medical centers in the U.S., Brazil, Canada, the Czech Republic, and Italy. Data from the study showed the devices to be effective in eliminating symptomatic recurrence of atrial fibrillation episodes for one year in about 63% of treated patients vs. 17% of the patients in the control group.
The catheters were the focus of an FDA Circulatory System Devices advisory panel last November, when they received the panel's unanimous recommendation for approval (Medical Device Daily, Nov. 24, 2008).
Biosense Webster specializes in diagnostic, therapeutic and mapping tools.