MARLBOROUGH, Mass.,
Nov. 8, 2017 /PRNewswire/
-- Updated guidelines issued by the American Heart Association
(AHA), the American College of Cardiology (ACC) and the Heart
Rhythm Society (HRS) now formally recommend the use of a
subcutaneous implantable cardioverter-defibrillator (S-ICD) for the
treatment of patients with ventricular arrhythmias and the
prevention of sudden cardiac death.1 The Boston
Scientific (NYSE: BSX) EMBLEM™ MRI S-ICD System is the only S-ICD
on the market, and the only implantable defibrillator available
that provides protection for patients at risk of sudden cardiac
death without touching the heart.
Co-published in Circulation, the Journal of the
American College of Cardiology (JACC) and the Heart Rhythm
Journal (HRJ), the "2017 AHA/ACC/HRS Guideline for Management
of Patients with Ventricular Arrhythmias and the Prevention of
Sudden Cardiac Death" supports the use of an S-ICD device with a
Class IIa recommendation for all patients who meet the criteria for
an implantable cardioverter-defibrillator (ICD) without a need for
pacing. The guidelines also strongly recommend the use of an S-ICD
device as the standard of care with a Class I recommendation for
the subset of these patients who have inadequate vascular access or
are at high risk for infection, including those with diabetes
mellitus.
Patients at high risk for infection often have limited venous
access which can result in a prolonged or failed implantation of a
transvenous ICD (TV-ICD). Per a recent analysis of more than 6,400
patients, those implanted with TV-ICD were at an eight-fold higher
rate of lead complications than patients who received an S-ICD
device.2
"The addition of the S-ICD System to these clinical guidelines
reinforces the value this device can bring to a broad
ICD-indicated patient population, through avoidance of transvenous
lead-specific complications," said Kenneth
Stein, M.D., senior vice president and chief medical
officer, Rhythm Management and Global Health Policy, Boston
Scientific. "The clinical significance of the updated guidelines
provides a call to action for physicians to include the S-ICD
System in shared decision making with their ICD-indicated
patients."
Earlier this year, the HRS recommended private health insurance
companies update any limited or unavailable coverage to ensure all
patients with appropriate clinical rationale have access to therapy
with the S-ICD device. Positive coverage policies for the S-ICD
System have been established by the Centers for Medicare and
Medicaid Services and private payers representing more than 90% of
insured individuals in the U.S.
The S-ICD System is included in the European Society of
Cardiology guidelines, published in 2015, for the management of
patients with ventricular arrhythmias and the prevention of sudden
cardiac death.
For more information on the EMBLEM MRI S-ICD System, 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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CONTACTS:
Laura Aumann
Media Relations
(651) 582-4251 (office)
Laura.Aumann@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
investor_relations@bsci.com
1 Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ,
Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC,
Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN,
Matlock DD, Myerburg RJ, Page RL, 2017 AHA/ACC/HRS Guideline for
Management of Patients With Ventricular Arrhythmias and the
Prevention of Sudden Cardiac Death, Heart Rhythm (2017),
doi: 10.1016/j.hrthm.2017.10.036.
2 Indranill Basu-Ray, et al. "Subcutaneous Versus
Transvenous Implantable Defibrillator Therapy." JACC: Clinical
Electrophysiology. Sep 2017, 496;
DOI: 10.1016/j.jacep.2017.07.017
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SOURCE Boston Scientific