Enrollment Underway in CLARITY-AF Study to Compare Efficacy, Safety and Efficiency of Two Catheter Ablation Technologies

July 8, 2010

WATERLOO, Belgium, July 8, 2010 /PRNewswire/ — Biosense Webster, Inc., a
worldwide leader in the diagnosis and treatment of cardiac arrhythmias,
announces that more than 10 patients have now been enrolled in the
CLARITY-study (“CLARITY-AF”), comparing the efficacy, safety and efficiency
of CARTO(R) 3 System guided radiofrequency ablation using the NAVISTAR(R)
THERMOCOOL(R) catheter versus fluoroscopy guided radiofrequency ablation
using the Pulmonary Vein Ablation catheter(R) (PVAC(R), Ablation Frontiers,
Medtronic) in patients with paroxysmal atrial fibrillation
(Clinicaltrials.gov ID NCT01116557)

This prospective, multi-center, randomized (2:1), controlled, two-arm
clinical study will enroll up to 350 patients at up to 15 sites throughout
Europe. Patients in this study will be followed for one year after ablation.
The study is intended to test the hypothesis that the NAVISTAR(R)
THERMOCOOL(R) catheter using the CARTO(R) 3 System is superior to
fluoroscopy-guided PVAC(R) for efficacy and safety and will demonstrate
non-inferiority for efficiency comparing the NAVISTAR(R) THERMOCOOL(R)
catheter used with the CARTO(R) 3 System to the PVAC(R) catheter. Interim
results from the study will be disclosed after completion of the enrollment
phase and the final results will be available at the end of the 1-year follow
up period.

“The CLARITY-AF trial is the first multi-center randomized trial
comparing atrial fibrillation ablation devices. This trial will compare the
Medtronic PVAC(R) catheter to the Biosense Webster NAVISTAR(R) THERMOCOOL(R)
catheter. Primary endpoints are freedom from any atrial fibrillation, atrial
tachycardia, pulmonary vein stenosis and procedure time. Given the growing
epidemic of atrial fibrillation, the results of this trial will guide optimal
treatment in a large patient population” said Prof. Mattias Duytschaever from
AZ St Jan Hospital in Bruges, Belgium, and principal investigator of the

With this study Biosense Webster shows its commitment to working towards
a cure for atrial fibrillation and improving the quality of life of patients
suffering from this disease. Atrial fibrillation is the most prevalent heart
rhythm disorder, increasing in prevalence with age. Clinical data suggests
that 20% of all strokes result from the illness, which often remains
undiagnosed and which can increase the risk of a stroke fivefold.

“The CLARITY-AF study will rigorously evaluate the efficacy, safety and
efficiency of the Biosense Webster NAVISTAR(R) THERMOCOOL(R) catheter with
CARTO(R) 3 System guidance compared to the Medtronic Pulmonary Vein Ablation
catheter(R) (PVAC(R)) with fluoroscopy for treating paroxysmal atrial
fibrillation. With enrollment now started, we are confident that this
scientific study will demonstrate objective results that will show the
superiority of the NAVISTAR(R) THERMOCOOL(R) catheter system for treating
atrial fibrillation”, according to Shlomi Nachman, World Wide President of
Biosense Webster. “We look forward to releasing the early results next year.”

CARTO(R) 3 is the third generation of the CARTO(R) electro-anatomical
mapping system, which brings the technology to an unprecedented level of
performance. The system has been designed based on the feedback provided by
several of the most prominent Key Opinion Leaders in the atrial fibrillation
treatment arena. CARTO(R) 3 is built on the core magnetic based CARTO(R)
proprietary technology, which has been recognized as the gold standard in its
domain, with a special focus on increased performance, ease of use and
Electrophysiology-lab efficiency.

The NAVISTAR(R) THERMOCOOL(R) catheter, manufactured by Biosense Webster,
Inc. is one of the most widely adopted catheters for the treatment of atrial
fibrillation in Europe, and the only ablation catheter approved by the U.S.
Food and Drug Administration for the treatment of drug refractory recurrent
symptomatic paroxysmal atrial fibrillation when used with CARTO(R) Navigation

According to data which appeared earlier this year in JAMA (Journal of
American Medical Association, January 2010), patients with a common heart
rhythm disorder, called atrial fibrillation, who were treated with catheter
ablation using the NAVISTAR(R) THERMOCOOL(R) catheter, demonstrated
significantly better outcomes at one year compared to those receiving drug
therapy. In addition, the patients treated with catheter ablation reported
markedly fewer symptoms and substantially improved quality of life.

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 one of the leaders 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.

The third party trademarks used herein are trademarks of their respective

    Ulrike Domany
    Director Public Affairs & Communication

SOURCE Biosense Webster, Inc.

Source: newswire

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