Biosense Webster Receives FDA Clearance for the CARTO® 3 System

State-of-the-Art Navigational Mapping System Offers Unique Combination of
Accuracy, Speed and Efficiency
DIAMOND BAR, Calif.--(Business Wire)--
Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of
cardiac arrhythmias, announced today that the U.S. Food and Drug Administration
(FDA) has cleared for marketing the CARTO® 3 System, the most advanced
three-dimensional imaging technology for use by electrophysiologists in treating
cardiac arrhythmias, commonly referred to as irregular heart rhythms.

It is estimated that 20 million people in the United States suffer from some
sort of arrhythmia. Atrial Fibrillation, or AFib as it`s more commonly known, is
the most prevalent cardiac arrhythmia affecting between 2.3 to 5.6 million
adults in the United States alone and is the leading cause of stroke among
people 65 years and older.

"The CARTO® 3 System is the world`s most sophisticated 3D mapping platform on
the market today and builds upon our long-standing commitment to
electrophysiologists and their patients," said Shlomi Nachman, Worldwide
President, Biosense Webster, Inc.

The CARTO® 3 System offers three unique features: Advanced Catheter Location
(ACL) Technology, Fast Anatomical Mapping (FAM), and a streamlined workflow
feature set referred to as CONNECTION OF CHOICE™. These three features work in
tandem to enhance a physician`s ability to treat an array of simple and complex
cardiac arrhythmias.

ACL is a hybrid technology that allows for accurate catheter tip and curve
visualization without spatial distortion. This helps the electrophysiologist to
orient catheters with precision for diagnostic and therapeutic applications. The
system can visualize up to five catheters simultaneously with clear distinction
of all electrodes.

FAM is a leading-edge technology that quickly and accurately creates
high-resolution, CT-like maps as quickly as an EP can move his or her catheter
throughout the cardiac chamber. FAM technology also permits detailed visual
enhancement of a specific area of interest within the heart.

CONNECTION OF CHOICE™ is enabled by the brand new CARTO® System hardware
configuration featuring a central connection point for all catheters and
equipment while preserving the signal quality of intracardiac electrograms.
Catheter connections have been re-designed for "plug-and-play" functionality and
automatic catheter recognition. All of these enhancements have been developed to
streamline and simplify workflow in the EP lab.

"Procedure time is consistently cited by EPs as the most significant barrier to
increased use of ablation therapy to treat cardiac arrhythmias," said Nachman.
"All of the enhancements offered by the CARTO® 3 System have been developed to
streamline and simplify workflow in the EP lab."

One of the leaders of the recent external evaluations, Vivek Y. Reddy, M.D.
offered praise for the CARTO® 3 System.

"The CARTO® 3 System is an exciting technology that represents a major step
forward for electrophysiologists. I was especially impressed with the Fast
Anatomical Mapping [FAM] feature. I was able to create a map quickly and the
accuracy was excellent," said Vivek Y. Reddy, M.D., Director, Cardiac Arrhythmia
Service, The Zeng and Michael A. Wiener Cardiovascular Institute, The
Marie-Josee and Henry R. Kravis Center for Cardiovascular Health. Dr. Reddy is
also Professor of Medicine, Mount Sinai School of Medicine in New York City. "In
addition, I was pleased with how the system merged with our CT scan. Overall,
the evaluation was a great experience for the whole lab team who enjoyed the new
quick system set up."

The CARTO® 3 System is the latest in a series of innovations from Biosense
Webster. In recent months, the company has launched the NAVISTAR® RMT
THERMOCOOL® Catheter in the U.S. and Europe and the EZ STEER® THERMOCOOL®
Bi-Directional Catheter in the U.S.

Earlier this year, the FDA approved the NAVISTAR® THERMOCOOL® Catheter,
including its bidirectional EZ STEER® Catheter platform, as safe and effective
for the treatment of drug refractory recurrent symptomatic paroxysmal atrial
fibrillation when used with the CARTO® System. The NAVISTAR® THERMOCOOL®
Catheters are the first and the only ablation catheters approved by the FDA for
the treatment of AFib.

Dr. Reddy is compensated for his time as a consultant to Biosense Webster.

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® XP System, 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.

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For Biosense Webster, Inc.:
Christopher Allman, 908-541-4807
Mobile: 305-586-6024

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