Biosense Webster to Support Landmark Clinical Trial of Atrial Fibrillation

AFib, as it is more commonly referred to, is the most prevalent cardiac arrhythmia (heart rhythm disorder), affecting an estimated 20 million people worldwide. It is also one of the most common causes of stroke.

Biosense Webster joins the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health, and another medical device company to fund the CABANA trial (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation), which has been designed and will be coordinated by Mayo Clinic.

"Biosense Webster is proud to be a substantial part of CABANA, a truly landmark trial that will provide important information to patients and physicians about treatment options for AFib, a significant risk factor for stroke," said Marcia Yaross, PhD., Vice President, Clinical, Regulatory and Health Policy, Biosense Webster, Inc. "Our investment in this study is part of our commitment to the principles of evidence-based medicine."

In addition to assessing whether catheter ablation is more effective than drug therapy for the treatment of AFib, the CABANA trial also will gather valuable information about the long-term complications of AFib including death, disabling stroke, serious bleeding, cardiac arrest, AFib recurrence, stroke risk, quality of life and cost-effectiveness.

CABANA will randomize approximately 3,000 patients over three years with half receiving catheter ablation and the other half receiving medical therapy for heart rate or rhythm control. The trial, which is expected to take six years from beginning to presentation of trial results, will involve approximately 140 medical centers from the U.S., Canada and Europe. Douglas Packer, M.D., Mayo Clinic, Rochester, MN, will serve as the principal investigator.

The results from the CABANA trial will add to the growing body of clinical evidence comparing catheter ablation to drug therapy for AFib and is designed to go beyond preceding trials, which did not have the ability to examine long term risks of mortality and stroke.

AFib: Growing Statistics and Current Treatment Options

According to the Olmstead County data (Miyasaka et al., Circ, 2006), 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 20 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 anti-arrhythmia drugs (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.

Cardiac ablation is an important therapeutic tool in treating arrhythmias. It is the standard of care for 'simple' arrhythmias, like Wolff-Parkison-White Syndrome, Type I atrial flutter and atrioventricular nodal re-entry tachycardia (AVNRT). It is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation.

In 2006, the leading medical societies including the American Heart Association, American College of Cardiology and the European Society of Cardiology recognized catheter ablation as second-line therapy for AFib.

About Biosense Webster, Inc.

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. With proprietary products such as the CARTO(R) XP System, the CARTOSOUND(TM) Image Integration Software Module, the THERMOCOOL(R) Irrigated Tip Catheter and the LASSO(R) Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

On February 6, 2009, the U.S. Food and Drug Administration granted Premarket Approval to the NaviStar(R) ThermoCool(R) Catheter, including its bidirectional EZ Steer(R) platform, as safe and effective for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with compatible three-dimensional electroanatomic mapping systems. The NaviStar(R) ThermoCool(R) catheters, developed by Biosense Webster, are the first and the only ablation catheters approved by the FDA for the treatment of AFib.

For more information about Biosense Webster and its products, visit www.biosensewebster.com.

SOURCE: Biosense Webster, Inc.

For Biosense Webster, Inc. 
Christopher Allman, 908-541-4807 or (m) 305-586-6024