DIAMOND BAR, Calif.–(BUSINESS WIRE)–Biosense Webster, Inc.,
a worldwide leader in the diagnosis and treatment of cardiac arrhythmias,
announced the FDA approval of the new THERMOCOOL® SF irrigated ablation catheter
in the United States.
The THERMOCOOL® SF NAV Catheter combines Biosense Websters latest
irrigated ablation technology with the accurate visualization of the CARTO®3 3D
Mapping & Ablation System. The catheter was launched in Europe
in October, 2010 and has received excellent feedback from electrophysiologists
who have used the product.
The THERMOCOOL® SF NAV Catheter is approved in the United States
for treatment of drug refractory recurrent symptomatic paroxysmal atrial
fibrillation when used with CARTO® Systems and Type 1 Atrial Flutter for
patients 18 years and older.
Unlike competitive irrigated technologies, the innovative
catheter design and breakthrough porous tip technology with Surround Flow
technology of the THERMOCOOL® SF Catheter allows for uniform cooling of the
entire catheter tip, and efficient heat dissipation when ablating. This cutting
edge innovation provides more effective cooling and allows half the volume load
to the patient, when compared to the traditional THERMOCOOL® Catheter.
“We are proud to offer electrophysiologists in the United States
our latest irrigated ablation technology to help treat patients with cardiac
arrhythmias,” said Shlomi Nachman, Worldwide President, Biosense Webster. “With
the introduction of the THERMOCOOL® SF Catheter, we reinforce our market
leadership in the electrophysiology marketplace and our passion for excellence
in knowledge and innovation.”
About AF and cardiac ablation
Atrial Fibrillation 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 ~130,000 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 commonly
used for “simple” arrhythmias, like Wolff-Parkinson-White Syndrome and
atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being
used for more complex arrhythmias like ventricular tachycardia and atrial
fibrillation. THERMOCOOL® Navigation Catheters are approved for drug refractory
recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO®
Systems (excluding the NAVISTAR® RMT THERMOCOOL® Catheter).
About Biosense Webster, Inc.
Biosense Webster, Inc., a Johnson & Johnson company, pioneered EP
diagnostic catheters more than 20 years ago and continues to lead the industry
as an innovative provider of advanced cardiac diagnostic, therapeutic, and
mapping tools. As the leader in EP navigation systems and ablation therapy,
Biosense Webster, Inc. has technology that includes the largest installed base
of cardiac mapping navigation systems worldwide in leading hospitals and teaching
institutions. For more information about Biosense Webster and its products,
please visit: www.biosensewebster.com (this site is intended for US
Posted by Sean Fenske, Editor-in-Chief, MDT