MARLBOROUGH, Mass.,
June 22, 2015 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) has initiated a worldwide study to evaluate
the rate and causes of shocks for patients implanted with the
EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) for primary
prevention of sudden cardiac death in the setting of severely
reduced cardiac function (left ventricular ejection
fraction </= 35 percent). Primary prevention
patients do not have a previously documented life-threatening
arrhythmic event, but are at risk of sudden cardiac death and
thereby indicated to receive an implantable defibrillator. This
group of patients represents the highest proportion of patients
that are implanted with transvenous ICD (TV-ICDs) devices today in
the United States (U.S.) and
European Union (EU).
In order to further demonstrate the usefulness of the S-ICD
System in this particular patient population, the UNTOUCHED study
will compare outcomes during an 18-month follow-up period to
objective performance criteria derived from the Multicenter
Automatic Defibrillator Implantation Trial-Reduce Inappropriate
Therapy (MADIT-RIT) study. The landmark MADIT-RIT study evaluated
shock rates in 1,500 patients implanted with TV-ICD devices and is
one of the largest randomized trials to assess shock reduction
strategies for TV-ICD devices.i
"The MADIT-RIT trial demonstrated that standardized programming
using higher rate cutoffs and longer delays to therapy reduces the
incidence of inappropriate shocks for TV-ICDs," said Dr.
Lucas Boersma, EU principal
investigator and electrophysiologist at St. Antonius Hospital,
The Netherlands. "The UNTOUCHED
trial will examine the incidence of all-cause shocks when using the
EMBLEM S-ICD System with standardized therapy settings similar to
MADIT-RIT."
The first patient enrolled in the global, multi-site,
prospective, non-randomized study received an EMBLEM S-ICD System
implant by Dr. Craig Barr,
cardiologist at Russells Hall Hospital in Dudley, England. The study will enroll a
minimum of 2,015 patients at up to 200 sites worldwide. Enrollments
in the U.S. will begin later this summer.
"In the published data to date, we have observed S-ICD devices
demonstrate comparable inappropriate shock rates for arrhythmias to
TV-ICDs," said Michael Gold, M.D.,
Ph.D., U.S. principal investigator and chief of cardiology and the
Michael E. Assey professor of
medicine at Medical University of South
Carolina, Charleston.
"Ideally, this trial will demonstrate S-ICD devices can either meet
or improve upon the inappropriate shock rates experiences with
TV-ICDs in MADIT-RIT within this large patient population."
The EMBLEM S-ICD System – the next generation of the Boston
Scientific S-ICD System – received CE mark earlier this year, was
approved by the Food & Drug Administration (FDA) in March of
2015, launched in Europe starting
in May, and became commercially available in the U.S. earlier this
month in preparation for a planned full U.S. launch during the
third quarter of 2015.
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology
leader for more than 35 years, we advance science for life by
providing a broad range of high performance solutions that address
unmet patient needs and reduce the cost of healthcare. For
more information, visit www.bostonscientific.com and connect on
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CONTACTS
Media: Trish Backes
Boston Scientific Corporation
651-582-5887 (office)
Trish.Backes@bsci.com
Investors: Susie Lisa, CFA
Boston Scientific Corporation
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investor_relations@bsci.com
i Moss AJ, et al. Reduction in inappropriate therapy
and mortality through icd programming. N Engl J Med.
2012;367:2275-2283
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SOURCE Boston Scientific