Biosense Webster, Inc., a worldwide leader in the diagnosis and
treatment of cardiac arrhythmias, announced today that it has received
approval from the United States Food and Drug Administration (FDA) for
its THERMOCOOL® SMARTTOUCH® Catheter. This device
is the first therapeutic catheter approved in the U.S. that enables
direct and real-time measurement of contact force during catheter
ablation procedures for patients suffering from drug-resistant
paroxysmal atrial fibrillation (Afib), sustained monomorphic ischemic
ventricular tachycardia and Type I atrial flutter.
Biosense Webster's THERMOCOOL® SMARTTOUCH® Catheter (Photo: Business Wire)
Providing doctors with contact force stability when applying
radiofrequency energy (RF) against the heart wall during catheter
ablation has been shown to improve outcomes as inconsistent tissue
contact may result in incomplete lesion formation that could result in
the need for additional treatment, and too much contact may result in
tissue injury, which may lead to complications. The THERMOCOOL®
SMARTTOUCH® Catheter enhances a physician’s ability to
achieve stable and consistent application of contact force by providing
direct, real-time quantitative feedback graphically displayed on the
company’s CARTO® 3 System upon tissue contact. Without this
technology, catheter tip-to-tissue contact has to be estimated through
other indirect measures such as electrogram parameters and impedance but
they have been shown to be poor predictors of contact force.1
“The THERMOCOOL® SMARTTOUCH® Catheter is an
important new device that will benefit the electrophysiology community,
as it will enable us to more precisely control the amount of contact
force applied to the heart wall when creating lesions during catheter
ablation,” said Andrea Natale, MD, Primary Investigator of the SMART-AF
Trial and Executive Medical Director of the Texas Cardiac Arrhythmia
Institute at St. David's Medical Center in Austin, TX. “Data from the
SMART-AF Trial demonstrated that consistent and stable application of
contact force has a significant impact on patient outcomes. The use of
contact force-sensing technology has emerged as a critical tool in
delivering optimal outcomes in the treatment of patients with atrial
fibrillation and represents a major advancement for the clinical
community.”
The safety and effectiveness of the THERMOCOOL® SMARTTOUCH®
Catheter were evaluated as part of a prospective, multicenter study
called the SMART-AF Trial in patients with drug-resistant symptomatic
paroxysmal atrial fibrillation. One-year results from the trial showed
that patients experienced a 74 percent overall success rate after
treatment with the THERMOCOOL® SMARTTOUCH®
Catheter. Importantly, data from the trial showed higher success rates
the longer physicians stayed within a targeted contact force range, with
one-year results demonstrating an 88 percent success rate when
physicians stayed within a targeted range greater than or equal to 85
percent of the time. The trial demonstrated for the first time that it
is the consistent and stable application of contact force on the heart
wall that positively impacts the efficacy of the procedure in this
patient population.
“We are pleased to be able to introduce this important advancement to
help clinicians enhance the quality of care they deliver for the
thousands of U.S. atrial fibrillation patients in need of alternative
treatments to drug therapy,” said David Shepherd, Worldwide President of
Biosense Webster. “The burden of atrial fibrillation on quality of life,
morbidity and mortality is well-documented and we are committed to
developing life-enhancing therapies to continue addressing unmet needs
in this space.”
About Atrial Fibrillation and Catheter Ablation
Atrial fibrillation, or Afib, is the most prevalent heart rhythm
disorder and is a leading cause of stroke among people 65 years and
older. An estimated three million people in the U.S. and 20 million
worldwide are affected by Afib and its prevalence is projected to
increase significantly as the population ages. Afib is a progressive
disease and increases in severity and frequency as patients get older.
Left untreated, it can lead to heart valve disease, sleep apnea, chronic
fatigue, congestive heart failure and stroke. The public health
implications of Afib are a growing concern because those with Afib are
at an increased risk of morbidity and mortality as well as a reduced
quality of life. It is estimated to be responsible for 88,000 deaths and
$16 billion in additional costs to the U.S. healthcare system on an
annual basis.2 During catheter ablation, doctors insert a
therapeutic catheter through a small incision in the groin where it is
then weaved up to the heart through a blood vessel. Once it reaches the
left upper chamber of the heart (atrium), radiofrequency energy is
delivered to the heart wall to create lesions that block faulty
electrical impulses that can cause heart rhythm disorders.
About Biosense Webster
Biosense Webster, Inc. is the global leader in the science of diagnosing
and treating heart rhythm disorders. The company partners with
clinicians to develop innovative technologies that improve the quality
of care for arrhythmia patients worldwide. Biosense Webster is part of
the Johnson & Johnson Family of Companies. More information can be found
on www.biosensewebster.com.
Dr. Natale is compensated for his services as a member of the company's
scientific advisory board and provides other consulting services.
1 Nakagawa H, Kautzner J, Natale A, et al. Locations of high
contact force during left atrial mapping in atrial fibrillation
patients: electrogram amplitude and impedance are poor predictors of
electrode-tissue contact force for ablation of atrial fibrillation. Circ
Arrhythm Electrophysiol 2013;6:746-53.
2 Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL.
Estimation of total incremental health care costs in patients with
atrial fibrillation in the United States.Circ Cardiovasc Qual Outcomes
2011;4:313–320.25
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