ImageBiosense Webster, Inc., a Johnson & Johnson company, announced that the US Food and Drug Administration (FDA) has granted marketing approval to the Navistar Thermocool Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. Atrial fibrillation, or AFib, is a highly prevalent heart rhythm disorder and one of the most common causes of stroke.

On November 20, 2008, the FDA's Circulatory System Devices Panel unanimously recommended approval of the Navistar Thermocool Catheter for AFib. The Navistar Thermocool Catheter is the first and only ablation catheter in the US to be approved for the treatment of this disorder, which affects an estimated 10 million people worldwide.

"Today's announcement is a milestone for electrophysiologists, physicians who specialize in heart rhythm disorders, and their patients throughout the US," said Marcia S. Yaross, Ph.D., vice president, 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."

Conditions of approval include a post-marketing registry and a physician education programme about use of the product.

The Navistar Termocool Catheter is also approved in the US for the treatment of type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction (heart attack). Atrial flutter and ventricular tachycardia are two types of cardiac arrhythmia.

"Since it was founded, Biosense Webster has been a leading provider of innovative products for the treatment of heart rhythm disorders and continues to partner with electrophysiologists to help advance ablation options for the millions of patients with these conditions," said Shlomi Nachman, Worldwide president, Biosense Webster. "Today's approval continues our legacy of innovation."

AFib is the most prevalent arrhythmia, affecting between 2.3 to 5.6 million adults in the United States, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 10 million people have AFib, yet fewer than 80,000 are treated through ablation. The public health implications of AFib are a growing concern because those with the condition are at an increased risk of morbidity and mortality as well as a reduced quality of life.

Most patients with AFib today are treated with AADs even though about half of them are refractory to these drugs. During cardiac ablation, a catheter is inserted into the heart and energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. This energy "disconnects" the pathway of the abnormal rhythm.

Biosense Webster, Inc., a Johnson & Johnson company, pioneered electrophysiology diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic and mapping tools. As the leader in navigation systems and ablation therapy, Biosense Webster, Inc.'s technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions.