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Devices Cardiology

 News Release - November 22, 2010

Patients With Common Heart Rhythm Disorder Demonstrated Improvements in Symptoms and Quality of Life With Catheter Ablation Compared to Treatment With Drug Therapy

WATERLOO, Belgium, November 22, 2010 -- (Healthcare Sales & Marketing Network) -- According to data published last week in Circulation Cardiovascular Quality and Outcomes, patients with a common heart rhythm disorder, called atrial fibrillation, who were treated with catheter ablation using the NaviStar(R)ThermoCool(R) Catheter, reported markedly fewer symptoms and substantially improved quality of life than patients treated with antiarrhythmia drugs at one year.

Atrial fibrillation, or AFib as it is more commonly referred to, is the most prevalent heart rhythm disorder, affecting an estimated 20 million people worldwide. It is also one of the most common causes of stroke among people 65 years and older. On average, patients with AFib have significantly reduced quality of life compared to the general population, and their impairment may be similar to that of patients suffering from severe chronic illnesses, such as kidney disease and heart failure.

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. The NaviStar(R)ThermoCool(R) Catheter, manufactured by Biosense Webster, Inc., is the only ablation catheter approved by the U.S. Food and Drug Administration for the treatment of drug refractory recurrent symptomatic paroxysmal AFib when used with Carto(R) Navigation Systems.NaviStar(R)ThermoCool(R) Catheter and Carto(R) Navigation System are CE marked since 1998 and 1994 respectively.

The primary study data published in JAMA in January 2010 demonstrated that at one year, 66% of patients treated with catheter ablation remained free from documented symptomatic AFib, compared to 16% of patients treated with medical therapy, also commonly referred to as anti-arrhythmic drugs or AADs (95% CI: 0.19, 0.47; P< .001).

A sub-study analysis published on 17th November 2010 in Circulation Cardiovascular Quality and Outcomes, demonstrates that quality of life scores that were 10% - 20% below population norms, as measured by a commonly used health survey called the Medical Outcomes Study Short Form-36 (SF-36), returned to population norms for patients treated with ablation, but did not change with drugs. Additionally, symptom frequency and severity scores, measured using the AF Symptom Checklist, decreased by greater than 50% in the ablation group, but were unchanged in the drug group.

"An in-depth analysis of the trial's data revealed that, for the population studied, 9 of 10 specific measures of quality of life and symptom burden - all except bodily pain - were superior in the group treated with catheter ablation, compared to the drug group," said Matthew Reynolds, MD, MSc, primary investigator for the sub-study and lead author, and Medical Director of the Economics and Quality of Life Assessment Group at the Harvard Clinical Research Institute in Boston. "These differences persisted for the duration of the trial and were strongly associated with recurrent arrhythmias, which were much more frequent in the antiarrhythmic drug group. These results add to a growing body of literature demonstrating that catheter ablation improves quality of life more than antiarrhythmic drugs in appropriately selected patients."

AFib: Growing Statistics and Current Treatment Options

AFib is the most prevalent heart rhythm disorder, yet only an estimated 110,000 patients per year are treated with ablation. Most patients with AFib today are treated with AADs even though in about half of them, the drugs do not control the AFib symptoms.

"The results of this study provide important information for patients with AFib and their physicians because it demonstrates that effective treatment of AFib through an intervention like ablation can reduce the severity of their symptoms and improve the quality of their life," said Dr. Reynolds.

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

In addition to his role as the primary investigator for this sub-study analysis, Dr. Reynolds is compensated for his services as a member of the company's health policy advisory board and provides other consulting services.

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 its proprietary products the company is changing the way electrophysiologists diagnose and treat arrhythmias. Biosense Webster, a Division of Johnson & Johnson Medical SA, Waterloo, Belgium, is the European authorized representative of Biosense Webster, Inc.


Source: Biosense Webster

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