DIAMOND BAR, Calif.–(BUSINESS WIRE)–Biosense Webster Inc.,
a worldwide leader in the diagnosis and treatment of cardiac arrhythmias,
announced the completion of enrollment in their latest ground-breaking clinical
trial, the SMART-AF Investigational Device Exemption (IDE) study.
The SMART-AF study is designed to demonstrate the safety and
effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheter in the treatment of
symptomatic, drug-refractory, paroxysmal atrial fibrillation, and enrolled 173
patients at leading centers across the United States.
The THERMOCOOL® SMARTTOUCH™ Catheter is a major advancement
in RF catheter technology. It measures the contact force and direction that the
catheter exerts on the heart tissue in real time. As the size of therapeutic RF
lesions is affected by the extent of contact, the ability for physicians to
directly measure contact force, rather than having to rely on surrogate
measures, represents an important advance in catheter technology. The
THERMOCOOL® SMARTTOUCH™ Catheter is the latest addition to the market-leading
NAVISTAR® THERMOCOOL® Catheter family, which is FDA approved for the treatment
of symptomatic, drug-refractory, paroxysmal atrial fibrillation.
Dr. David Wilber, Director of Cardiology at Loyola University
and a member of the SMART-AF study advisory committee, said, “The THERMOCOOL®
SMARTTOUCH™ Catheter has been performing extremely well during my SMART-AF
cases. The ability to measure contact force and direction in real time, as I
map and ablate, is enabling me to maneuver the catheter confidently, and is
becoming a key measure in my procedures. Additionally, the integration of this
technology into the CARTO® 3 Mapping and Navigation System facilitates
incorporation into my workflow.”
Biosense Websters World-Wide President, Shlomi Nachman,
commented, “Completion of enrollment in 2011 is a great achievement, and an
indicator of the potential value the investigators see in this technology to improve
the treatment options for their patients. I would like to thank all the
investigators for their work meeting our aggressive timelines, so we can now
collect the follow up data which will be used for the submission to FDA.”
The THERMOCOOL® SMARTTOUCH™ Catheter is one of the most
advanced catheters developed by Biosense Webster to date. During cardiac
ablation procedures, the THERMOCOOL® SMARTTOUCH™ Catheter enables the
measurement of catheter tip contact force and direction inside the heart. This
information is graphically displayed on the CARTO®3 Mapping and Navigation
System with Software Version 2 or higher, the most advanced 3D mapping system
available on the market today, to create a fully integrated solution combining
contact force and 3D mapping and navigation capabilities.
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 Websters 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
Dr. Wilber is compensated for his services as a member of
the companys 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
For more information about Biosense Webster and its
products, please visit: www.biosensewebster.com.
Posted by Sean Fenske, Editor-in-Chief, MDT