MARLBOROUGH, Mass.,
Aug. 9, 2016 /PRNewswire/
-- Boston Scientific (NYSE: BSX) has received U.S. Food and
Drug Administration (FDA) approval for the EMBLEM™ MRI Subcutaneous
Implantable Defibrillator (S-ICD) System, as well as magnetic
resonance (MR) conditional labeling for all previously implanted
EMBLEM S-ICD Systems. The new EMBLEM MRI S-ICD System is the latest
addition to the company's growing line of ImageReady™
MR-conditional devices, which allow patients to undergo magnetic
resonance imaging (MRI) safely.
The EMBLEM S-ICD System is a proven treatment option for
patients at risk of sudden cardiac arrest, that leaves the heart
and vasculature untouched, thus reducing the risk of complications
associated with conventional transvenous implantable
cardioverter-defibrillator leads.
"Now with FDA approval, patients receiving the EMBLEM MRI S-ICD
System, as well as patients who previously were implanted with an
EMBLEM S-ICD System, have reassurance they can safely undergo MR
scans while remaining protected from cardiac arrest," said
Kenneth Stein, M.D., chief medical
officer, Rhythm Management, Boston Scientific.
Boston Scientific received CE Mark for the EMBLEM MRI S-ICD
System earlier this year and began commercialization in
Europe in June. In addition to
MR-conditional labeling, the device introduces two new features to
the market – SMART Pass technology and Atrial Fibrillation (AF)
Monitor™. The SMART Pass technology, also being added to previously
implanted EMBLEM S-ICD Systems through a software update, increases
the accuracy of the INSIGHT™ Algorithm to help ensure patients
receive appropriate therapy from the device only when necessary.
The AF Monitor feature is a detection tool designed to alert
physicians after the identification of AF so they can make more
informed treatment decisions for their patients.
Earlier this year, the company received FDA approval for the
ImageReady MR-Conditional Pacing System, which includes ACCOLADE™
MRI and ESSENTIO™ MRI pacemakers as well as INGEVITY™ MRI pacing
leads, designed to treat bradycardia. Patients implanted with the
full system are able to receive full-body MR scans in a 1.5 Tesla
environment when conditions of use are met. Additionally, the
company is actively pursuing MRI compatibility for their currently
approved implanted cardiac defibrillation and cardiac
resynchronization therapy systems via the global ENABLE MRI
study.
For more information on the EMBLEM S-ICD Systems 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:
U.S. Media: Laura Aumann
Boston Scientific Corporation
(651) 582-4251 (office)
Laura.Aumann@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation