Biosense Webster Successfully Completes First Clinical Atrial Fibrillation Ablation Cases in the European Union Using the

THERMOCOOL® SMARTTOUCH™ Catheter from Biosense Webster Enables Contact Force Sensing in the Ablation of Atrial Fibrillation

DIAMOND BAR, Calif.--(BUSINESS WIRE)-- Biosense Webster, Inc., a Johnson & Johnson company, and a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the successful completion of the first clinical cases with the new THERMOCOOL® SMARTTOUCH Contact Force Sensing Catheter in the European Union, following recent CE Mark approval. The device is pending clinical investigation in the U.S. and FDA has not yet approved it for sale.

The THERMOCOOL® SMARTTOUCH Catheter is the most advanced catheter developed by Biosense Webster to date. During cardiac ablation, the THERMOCOOL® SMARTTOUCH Catheter enables the measurement of catheter tip contact force and direction inside the heart. The force and contact information is graphically displayed on the CARTO® 3 Mapping and Navigation System with the CARTO® 3 SMARTTOUCH Software Module thus creating the only fully integrated solution in the electrophysiology market which combines contact force with 3D mapping and navigation capabilities.

Dr. Paolo Della Bella, from the San Raffaele Hospital in Milan, Italy, performed the first human cases with the THERMOCOOL® SMARTTOUCH Catheter and CARTO® 3 System. “This is a breakthrough technology. The force reading parameter gives me additional confidence in my ablation procedures.”

The THERMOCOOL® SMARTTOUCH Catheter combines Biosense Webster’s market-leading irrigated ablation technology and the accurate visualization for which the CARTO® 3 System is globally renowned with innovative force sensing capabilities. By displaying precise contact force and direction information, the THERMOCOOL® SMARTTOUCH Catheter provides an important new parameter for the mapping and ablation of complex cardiac arrhythmias, such as Atrial Fibrillation (AF).

“THERMOCOOL® SMARTTOUCH Catheter brings new force reading information to physicians and will provide them with an important new measurement for ablation procedures. This breakthrough technology continues our commitment to bringing advanced tools to the Cardiac Electrophysiology community, so that they may better serve their patients,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc.

About AF and cardiac ablation

AF 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 100,000 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.

Most patients with AF today are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs. 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 the standard of care for “simple” arrhythmias, like Wolff-Parkison-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. Biosense Webster’s NAVISTAR® THERMOCOOL® Irrigated Ablation Catheter remains the only FDA approved Radiofrequency Navigation catheter for the treatment of symptomatic drug refractory atrial fibrillation on the market today.

Dr. Della Bella 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., a Johnson & Johnson company, pioneered EP 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 the leader in navigation systems and ablation therapy, Biosense Webster, Inc. has technology that includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. By continuing to innovate with new products such as the THERMOCOOL® SMARTTOUCH Catheter, the company is changing the way EPs diagnose and treat cardiac arrhythmias.

For more information about Biosense Webster and its products, please visit: www.biosensewebster.com.



CONTACT:

Biosense Webster, Inc.
Sandra Pound, 908-541-4040
Mobile: 908-432-2829

KEYWORDS:   United States  North America  California

INDUSTRY KEYWORDS:   Health  Biotechnology  Cardiology  Medical Devices  Pharmaceutical  Other Health  General Health

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