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Press release from Business Wire

Biosense Webster Announces Launch of the THERMOCOOL® SF NAV Catheter With Curve Visualization

Thursday, May 10, 2012

Biosense Webster Announces Launch of the THERMOCOOL® SF NAV Catheter With Curve Visualization07:00 EDT Thursday, May 10, 2012 DIAMOND BAR, Calif. (Business Wire) -- Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the launch of the new THERMOCOOL® SF NAV irrigated ablation catheter with Curve Visualization in the United States. NEW Curve Visualization TechnologyThe THERMOCOOL® SF NAV Irrigated Ablation Catheter with Curve Visualization combines Biosense Webster's latest porous tip technology with the accurate visualization of the CARTO®3 3D Mapping & Ablation System. This enhanced technology is designed to reduce fluoroscopy exposure to physicians, lab staff and patients alike, enhance visualization of the ablation catheters orientation and improve procedural efficiency. Dr. Daniel Melby, Cardiac Electrophysiologist from the Minneapolis Heart Institute in Minneapolis, MN, was among the first to use the new technology in the United States. “The THERMOCOOL® SF Catheter with Curve Visualization provides substantial advantages over existing technologies. While using the Curve Visualization feature, the catheter position is more completely represented on the CARTO display, thereby allowing less fluoroscopy use and easier catheter positioning on difficult atrial locations. In addition, the THERMOCOOL® SF Catheter platform provides the ability to consistently ablate at all atrial locations without the limitation of overheating and with 50% less volume delivery to the patient." Porous Tip TechnologySince its introduction in January 2012, the THERMOCOOL® SF Catheter with Surround Flow technology has achieved widespread adoption within hundreds of hospitals throughout the United States. Unlike competitive irrigated technologies, the innovative catheter design and breakthrough porous tip technology with Surround Flow technology of the THERMOCOOL® SF Catheter allows for uniform cooling of the entire catheter tip, and efficient heat dissipation when ablating. This cutting edge innovation provides more effective cooling and allows half the volume load to the patient, when compared to the traditional THERMOCOOL® Catheter. The THERMOCOOL® SF NAV Catheter is approved in the United States for treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with CARTO® Systems and Type 1 Atrial Flutter for patients 18 years and older. Participation at Health Leadership Conference on Capitol Hill in Washington, DCBiosense Webster was invited to showcase the THERMOCOOL® SF Catheter with Curve Visualization technology during the Innovation Expo of the HealthCare Leadership Council on Capitol Hill in Washington, DC on April 25-26, 2012. Members of Congress were able to see the latest technology to treat Atrial Fibrillation, the most common arrhythmia impacting more than 5MM people in United States. About AF and cardiac ablationAtrial Fibrillation is the most prevalent arrhythmia, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 20 million people have AF, yet only ~130,000 are treated with ablation every year. The public health implications of AF are a growing concern because those with AF are at an increased risk of morbidity and mortality as well as a reduced quality of life. Today, most patients with AF are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs Cardiac Ablation offers a safe and efficacious alternative to treat cardiac arrhythmias. During cardiac ablation, 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. Cardiac ablation is commonly used for “simple” arrhythmias, like Wolff-Parkinson-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding the NAVISTAR® RMT THERMOCOOL® Catheter). Dr. Melby is compensated for his services as a member of the company's scientific advisory board and provides other consulting services. About Biosense Webster, Inc.Biosense Webster, Inc. pioneered EP diagnostic catheters more than 20 years ago and continues to lead the industry as an innovative provider of advanced cardiac diagnostic, therapeutic, and mapping tools. As the leader in EP navigation systems and ablation therapy, Biosense Webster, Inc. has technology that includes the largest installed base of cardiac mapping navigation systems worldwide in leading hospitals and teaching institutions. For more information about Biosense Webster and its products, please visit: www.biosensewebster.com (this site is intended for US visitors only). For Biosense Webster, Inc.Sandra Pound(o) 908 218-2720(m) 908-432-2829Spound@its.jnj.com