Biosense Webster Introduces the THERMOCOOL® SF Irrigated Catheter in the European Union

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced today the completion of the first clinical cases with the new THERMOCOOL® SF Irrigated Ablation catheter in the European Union, following recent CE Mark approval. The THERMOCOOL® SF catheter is the most advanced Biosense Webster irrigated ablation catheter for use by electrophysiologists in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms.

The THERMOCOOL® SF Irrigated catheter is the next generation in irrigated ablation catheters and builds upon the industry leading THERMOCOOL® irrigated catheter platform. The THERMOCOOL ® SF catheter’s unique design and porous tip technology provides EPs with uniform cooling across the entire catheter tip and allows efficient cooling at half the flow rate.

"The THERMOCOOL® SF Irrigated Catheter is the latest advancement in irrigated ablation catheter design with its groundbreaking and unique porous tip technology,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. "This innovation further builds upon our clear leadership position in the electrophysiology market and reinforces our long-standing commitment to electrophysiologists and their patients. "We are extremely pleased this exciting new product will be launched throughout the European Union over the coming months.”

Unlike competitive irrigated technologies which offer localized cooling, the cutting edge catheter design and breakthrough porous tip technology of the THERMOCOOL® SF catheter allow for uniform cooling of the entire catheter tip when ablating. This in turn allows for efficient fluid delivery within the catheter itself and allows heat to dissipate across the entire catheter tip. As a result, cooling efficiency is increased and the flow rate is reduced.

Prof. Gerd Hindricks of the Heart Center at the University of Leipzig Hospital commented on his recent experience with Biosense Webster’s new catheter platform. ”The THERMOCOOL® SF catheter is a new and exciting technology that represents a significant advancement in irrigated ablation for electrophysiologists”. "I have been extremely impressed with the features & capabilities of the THERMOCOOL ® SF catheter". "My first clinical experience indicates that due to the strategic placement of the holes around the entire surface area of the tip, cooling efficiency and lesion induction may be improved to complete Atrial Fibrillation ablation procedures in a safe, effective, and timely manner”.

"Procedure time & safety concerns are consistently cited by EPs as the most significant barrier to increased use of ablation therapy to treat cardiac arrhythmias,” added Nachman. "All of our products are being developed with the aim of addressing these concerns.”

The THERMOCOOL® SF catheter is the latest in a series of innovations from Biosense Webster. In recent months, the company has launched its ground-breaking new 3D mapping platform, the CARTO™ 3 System in Europe and the NAVISTAR ® & Celsius® RMT THERMOCOOL® Catheters globally.

The NAVISTAR® THERMOCOOL® Catheters, including its bidirectional EZ STEER® Catheter platform, remains the first and only US Food & Drug Administration approved catheter for the safe and effective treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with the CARTO® System.

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 the leader 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 ® 3 & CARTO® XP Systems, the CARTOSOUND® Image Integration Software Module, the THERMOCOOL® Irrigated Tip Catheter and the LASSO® Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

For more information about Biosense Webster, visit www.biosensewebster.com.