MARLBOROUGH, Mass.,
April 20, 2016 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) has received CE Mark approval for the new
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 EMBLEM S-ICD Systems are treatment options for patients at
risk of sudden cardiac arrest (SCA) that leave the heart and
vasculature untouched, reducing the risk of complications
associated with transvenous implantable cardioverter-defibrillators
(TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD
System has begun in a small number of European centers with a broad
European launch scheduled for early this summer.
In Europe, the EMBLEM MRI S-ICD
System joins the growing family of ImageReady™ MR-conditional
devices, all of which are labeled safe for use in a magnetic
resonance image setting when conditions of use are met. Patients
receiving the EMBLEM MRI S-ICD System as well as patients who
previously were implanted with an EMBLEM S-ICD System are now able
to undergo full-body MR scans safely in 1.5 Tesla environments when
conditions of use are met.
"These approvals give reassurance to physicians and their
patients that they have access to any future MR scan needs, and
underscores the Boston Scientific commitment to gain MR-conditional
labeling on high-voltage devices that are being implanted today,"
said Kenneth Stein, M.D., chief
medical officer, Rhythm Management, Boston Scientific. "Further,
the EMBLEM S-ICD System is a compelling treatment option for the
majority of ICD-indicated patients that provides protection from
cardiac arrest without invading the heart and blood vessels."
The EMBLEM MRI S-ICD System also includes two new features,
SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The
SMART Pass technology will help ensure patients receive therapy
from the device only when necessary by enhancing the INSIGHT™
Algorithm, which identifies and classifies a heart rhythm for
effective arrhythmia treatment. This novel feature will also be
added to previously implanted EMBLEM S-ICD Systems through a
software update. The AF Monitor feature of the EMBLEM MRI S-ICD
System is a new detection tool designed to alert physicians after
the identification of AF so they can make more informed treatment
decisions for their patients.
The company is actively pursuing U.S. Food and Drug
Administration (FDA) approval of the EMBLEM MRI S-ICD System as
well as MR-conditional labeling for previously implanted EMBLEM
S-ICD Systems. Additionally, the global ENABLE MRI study, initiated
earlier this year, is intended to support FDA approval for
MR-conditional labeling across the company's currently approved ICD
and cardiac resynchronization therapy systems.
For more information on the EMBLEM S-ICD Systems visit
www.sicdsystem.com.
In the U.S., the EMBLEM MRI S-ICD System is not available for
sale.
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
European Media: Simonetta
Balbi
39 010 6060281 (office)
Boston Scientific Corporation
Simonetta.Balbi@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