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Cardiology |
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| 16 Oct 2009 | Viewed: 103 | |
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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.
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| News Source: medical news today |
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