MARLBOROUGH, Mass.,
April 20, 2015 /PRNewswire/ -- Today
the Journal of the American College of Cardiology published
data confirming the long-term safety and efficacy of the Boston
Scientific Corporation (NYSE: BSX) S-ICD System™
(subcutaneous implantable defibrillator) for patients at risk of
sudden cardiac arrest.
The study, "Safety and Efficacy of the Totally Subcutaneous
Implantable Defibrillator: 2-year Results from a Pooled Analysis of
the IDE Study and EFFORTLESS Registry" was led by Dr. Martin Burke, professor of medicine at the
University of Chicago. The analysis
combined data from two large S-ICD studies to provide the most
comprehensive look at S-ICD System patient outcomes to date.
The S-ICD System – which was approved by the Food & Drug
Administration (FDA) in 2012 and which gained Category 1 CPT Codes
in January – was shown to be highly effective, converting more than
98 percent of heart arrhythmias that can lead to sudden death.
These data are comparable to efficacy outcomes found in transvenous
ICD (TV-ICD) clinical trials (95-99%)1-4.
When assessing 889 patients with a total of 1,571 patient-years
of follow-up, there were no lead failures and no systemic
infections associated with the S-ICD System. The total rate of
complications observed in this analysis was low relative to rates
found in comparable TV-ICD studies5,6. The rate of
cumulative complications increased by just one percentage point
annually after the first year (9% at one year; 10% at two years;
11% at three years). Major acute complications related to the
operation were lower than observed in studies with TV-ICD (2%[i]
versus 3-5%)7,8.
"The S-ICD device sits just below the skin without the need for
electrodes or leads to be placed into the heart and so it makes
sense that we see decreased serious complications," said Dr.
Burke. "By using the S-ICD System
we can avoid the key risks that cause systemic or endovascular
infections, which can add weeks to a hospital stay, incur tens of
thousands of dollars in incremental hospital costs, and which are
also associated with mortality for up to one-third of TV-ICD
patients who acquire this type of infection."
The all-cause mortality rate for the S-ICD patients was 1.6
percent per year, comparing favorably to observed mortality rates
in similar TV-ICD studies (2.5-5.5% per year)9-11.
This study combined data from the U.S. Investigational Device
Exemption study that led to the device's approval by the FDA
and also data from the EFFORTLESS registry, each with
extended follow-up (average 22 months) relative to previously
published reports on the S-ICD
System.
Currently, the S-ICD System is covered nationally by Medicare,
Aetna, Cigna and others, and regionally by numerous private and
Medicaid plans, providing coverage for approximately 170 million
individuals in the U.S.
The S-ICD System has been commercially available in Europe since 2009. For more information on the
S-ICD system, please visit www.bostonscientific.com/sicd.
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
Twitter and Facebook.
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Statements
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statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
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Item 1A – Risk Factors in our most recent Annual Report on
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CONTACT:
Trish Backes
651-582-5887 (office)
External Communications
Boston Scientific Corporation
trish.backes@bsci.com
Susie Lisa, CFA
508-683-5565 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com
[i] S-ICD complications included hematoma and lead/device
mal-positioning/displacement
1Swerdlow CD, et al. The dilemma of ICD implant
testing. Pacing Clin Electrophysiol 2007;30:675-700.
2Gold MR, et al. Efficacy and temporal stability of
reduced safety margins for ventricular defibrillation: primary
results from the Low Energy Safety Study (LESS). Circulation
2002;105:2043-2048.
3Cha YM, et al. Impact of shock energy and
ventricular rhythm on the success of first shock therapy: the
ALTITUDE first shock study. Heart Rhythm
2013;10:702-708.
4Kutyifa V, et al. Clinical impact, safety, and
efficacy of single- versus dual-coil ICD leads in MADIT-CRT. J
Cardiovasc Electrophysiol 2013;24:1246-1252.
5Kirkfeldt RE, et al. Complications after cardiac
implantable electronic device implantations: an analysis of a
complete, nationwide cohort in Denmark. Eur Heart J
2014;35:1186-1194.
6Ezzat VA, et al. A systematic review of ICD
complications in randomised controlled trials versus registries: is
our 'real-world' data an underestimation? Open Heart
2015;2:e000198.
7Peterson PN, et al. Association of single- vs
dual-chamber ICDs with mortality, readmissions, and complications
among patients receiving an ICD for primary prevention. JAMA
2013;309:2025-2034.
8van Rees JB, et al. Implantation-related
complications of implantable cardioverter-defibrillators and
cardiac resynchronization therapy devices: a systematic review of
randomized clinical trials. J Am Coll Cardiol
2011;58:995-1000.
9Moss AJ, et al. Reduction in inappropriate therapy
and mortality through ICD programming. N Engl J Med
2012;367:2275-2283.
10Healey JS, et al. Cardioverter defibrillator
implantation without induction of ventricular fibrillation: a
single-blind, non-inferiority, randomised controlled trial
(SIMPLE). Lancet 2015;385:785-791.
11 van der Heijden AC, et al. The clinical course of
patients with implantable defibrillators: Extended experience on
clinical outcome, device replacements, and device-related
complications. Heart Rhythm 2015.
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SOURCE Boston Scientific Corporation