WATERLOO, Belgium, April 8, 2010 Biosense Websterannounces that this week it has obtained its first Ethics Committee approvalfor the CLARITY study, comparing the 1-year efficacy, safety and efficiencyof CARTO(R) 3 System-guided radiofrequency ablation using the NAVISTAR(R)THERMOCOOL(R) Catheter versus fluoroscopy-guided radiofrequency ablationusing 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-armclinical study will enroll up to 350 patients at up to 15 sites throughoutEurope and Canada. The 1-year efficacy results are expected to be availableby Q2 2012, whereas the safety and efficiency data for both procedures willalready be available by Q2 2011.
"The CLARITY trial is the first randomized trial comparing the efficacyand safety of these existing ablation strategies for atrial fibrillation.Given the growing epidemics of atrial fibrillation, the results of thislandmark 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 acure for atrial fibrillation and improve the quality of life of patientssuffering from this disease, and be the #1 in rhythm solutions globally.Atrial fibrillation is the most prevalent heart rhythm disorder, increasingin prevalence with age. Clinical data suggest that 20% of all strokes resultfrom the illness, which often remains undiagnosed and which can increase therisk 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 providesuperior efficacy and safety for the treatment of paroxysmal atrialfibrillation vs. the PVAC(R) catheter, without decreasing the efficiency ofthe ablation procedure, according to Marcia S Yaross, Ph.D., Vice President,Worldwide Clinical, Regulatory and Health Policy, Biosense Webster. "We lookforward 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 anunprecedent level of performance. The system has been designed based on thefeedback provided by several of the most prominent Key Opinion Leaders in theatrial fibrillation treatment arena. CARTO(R) 3 System is built on the coremagnetic based CARTO(R) proprietary technology, which has been recognized asthe gold standard in its domain, with a special focus on increasedperformance, ease of use and EP lab efficiency.
The NAVISTAR(R) THERMOCOOL(R) Catheter, manufactured by Biosense Webster,Inc. is one of the most widely adopted catheter for the treatment of atrialfibrillation in Europe, and the only ablation catheter approved by the U.S.Food and Drug Administration for the treatment of drug refractory recurrentsymptomatic paroxysmal AFib when used with CARTO(R) Navigation Systems.
According to data recently appeared in JAMA (Journal of American MedicalAssociation, January 2010), patients with a common heart rhythm disorder,called Atrial Fibrillation, who were treated with catheter ablation using theNAVISTAR(R) THERMOCOOL(R) Catheter, demonstrated significantly betteroutcomes at one year compared to those receiving drug therapy. In addition,the patients treated with catheter ablation reported markedly fewer symptomsand substantially improved quality of life.
About Biosense Webster, Inc. Biosense Webster, Inc., a Johnson & Johnsoncompany, pioneered electrophysiology diagnostic catheters more than 30 yearsago and continues to lead the industry as an innovative provider of advanceddiagnostic, therapeutic and mapping tools. As one of the leaders innavigation systems and ablation therapy, Biosense Webster, Inc.'s technologyincludes the largest installed base of navigation systems worldwide inleading hospitals and teaching institutions. With proprietary products suchas the CARTO(R) XP System, the CARTOSOUND(R) Image Integration SoftwareModule, the THERMOCOOL(R) Irrigated Tip Catheter and the LASSO(R) CircularMapping Catheter, the company is changing the way electrophysiologistsdiagnose and treat arrhythmias.
The third party trademarks used herein are trademarks of their respectiveownersCARTO(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
SOURCE Biosense Webster Inc.