Bringing “CLARITY” on Efficacy, Safety and Efficiency of Catheter Ablation of Atrial Fibrillation

April 8, 2010

WATERLOO, Belgium, April 8, 2010 /PRNewswire/ — Biosense Webster
announces that this week it has obtained its first Ethics Committee approval
for the CLARITY study, comparing the 1-year 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.

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 and Canada. The 1-year efficacy results are expected to be available
by Q2 2012, whereas the safety and efficiency data for both procedures will
already be available by Q2 2011.

“The CLARITY trial is the first randomized trial comparing the efficacy
and safety of these existing ablation strategies for atrial fibrillation.
Given the growing epidemics of atrial fibrillation, the results of this
landmark trial will guide optimal treatment in a large patient population”
said Prof. Mattias Duytschaever, principal investigator of the CLARITY study.

With this study Biosense Webster shows its commitment to work towards a
cure for atrial fibrillation and improve the quality of life of patients
suffering from this disease, and be the #1 in rhythm solutions globally.
Atrial fibrillation is the most prevalent heart rhythm disorder, increasing
in prevalence with age. Clinical data suggest that 20% of all strokes result
from the illness, which often remains undiagnosed and which can increase the
risk of a stroke fivefold.

The hypothesis of this trial is that treatment with the NAVISTAR(R)
THERMOCOOL(R) Catheter, with CARTO(R) 3 System guidance, will provide
superior efficacy and safety for the treatment of paroxysmal atrial
fibrillation vs. the PVAC(R) catheter, without decreasing the efficiency of
the ablation procedure, according to Marcia S Yaross, Ph.D., Vice President,
Worldwide Clinical, Regulatory and Health Policy, Biosense Webster. “We look
forward to working with experienced PVAC(R) and NAVISTAR(R) THERMOCOOL(R)
users in Europe and Canada to evaluate this hypothesis.”

CARTO(R) 3 System is the third generation of the CARTO(R)
electro-anatomical mapping System, which brings the technology to an
unprecedent 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 System 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 EP lab efficiency.

    CARTO(R) 3 System brings to the physician and his/her staff:

    - Accurate visualization (with CARTO(R) proprietary 3D
      mapping technology), which allows seeing up to 5 catheters in the
      anatomy with precision and clarity, while potentially minimizing
      fluoroscopy exposure to patients, physicians and EP lab staff
    - Increased mapping speed, which enables to map as fast as
      moving the catheter, potentially shortening procedures and minimizing
      the burden to patients
    - Streamlined workflow allowing the physician and the lab teams
      to work more efficiently saving lab resources and minimizing
      potential for human errors
    - A new User Interface designed for the EP lab, to shorten the
      learning curve for nurses and for other staff members
    - An improved connectivity for catheters, enabling better
      signal quality and minimizing setup errors

The NAVISTAR(R) THERMOCOOL(R) Catheter, manufactured by Biosense Webster,
Inc. is one of the most widely adopted catheter 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 AFib when used with CARTO(R) Navigation Systems.

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

The third party trademarks used herein are trademarks of their respective

    Contacts: PR Contact Ben Lyons
    Telephone: +44(0)20-7526-3622
    Or Ulrike Domany-Funtan
    Mobile: +43(664)83-504-83

SOURCE Biosense Webster Inc.

Source: newswire

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