Biosense Webster obtains first Ethics Committee approval for CLARITY study

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.