MARLBOUROUGH, Mass., Aug. 24, 2015
/PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has
received CE Mark on magnetic resonance imaging (MRI) conditional
labeling for the current family of EL (Extended Longevity) and MINI
implantable cardioverter defibrillator (ICD) and the X4 cardiac
resynchronization therapy defibrillator (CRT-D) systems. This
revised labeling ensures that future patients and those already
implanted with these systems are able to undergo MRI scans if
indicated.
Patients with implantable cardiac devices have a wide variety of
diagnostic imaging available to them, including x-rays and CT
scans, but Boston Scientific systems had not been evaluated as MRI
conditional. This new system labeling, referred to as
ImageReady™ MR Conditional devices, stipulates the
conditions under which the systems are considered safe for use in a
MRI setting.
"While the broader imaging compatibility will be important for
some patients, I still expect device longevity and the ability to
mitigate risk of complications to be the most critical factors in
choosing the best system for each patient," said Gianluca Botto, head of Electrophysiology and
Clinical Arrhythmias at S. Anna Hospital, Como, Italy and president of Italian Association of
Pacing and Arrhythmias.
"We are pleased to combine broader imaging options with our
long-lasting, high-voltage portfolio, offering additional value to
our exclusive EnduraLife™ battery technology for
European physicians and their patients," said Joe Fitzgerald, executive vice president and
president of the Rhythm Management division of Boston Scientific.
"We are seeking regulatory approvals for revised labeling and
updated software for these systems in major markets by
2017."
Adding ImageReady capabilities to virtually all high-voltage
products currently marketed – which include AUTOGEN™,
DYNAGEN™, INOGEN™ and ORIGEN™
devices – as well as ACUITY™ X4 quadripolar LV leads,
INGEVITY™ and FINELINE™ II pacing leads and
RELIANCE® 4-SITE™ and
4-FRONT™ defibrillator leads, gives Boston Scientific
the largest portfolio of MRI-compatible products in Europe.
MRI compatibility has not received regulatory approval in all
geographies. For a list of all ImageReady products visit
www.bostonscientific.com/imageready.
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
Media: Trish Backes
Boston Scientific Corporation
651-582-5887 (office)
Trish.Backes@bsci.com
Investors: Susie Lisa, CFA
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation