MARLBOROUGH, Mass.,
April 25, 2016 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) has received U.S. Food and Drug
Administration (FDA) approval for a suite of products deemed safe
for use in a magnetic resonance imaging (MRI) environment. The
ImageReady™ MR-Conditional Pacing System, which includes ACCOLADE™
MRI and ESSENTIO™ MRI pacemakers, as well as the new INGEVITY™ MRI
pacing leads, is designed to treat bradycardia, a condition in
which the heart beats too slowly. Patients implanted with the full
system are able to receive full-body MR scans in 1.5 Tesla
environments when conditions of use are met.
The newly-approved family of INGEVITY MRI pacing leads includes
active and passive fixation models. This marks the first time a
passive fixation pacing lead is approved for U.S. patients
undergoing MR scans.
Approval of the INGEVITY MRI leads, as well as the full
ImageReady System, was based on data from two global clinical
trials. The INGEVITY trial, a prospective, non-randomized study,
enrolled 1,036 patients and assessed safety, performance and
effectiveness of the leads in patients with a single or dual
chamber pacemaker. The SAMURAI trial, a prospective, randomized
study, enrolled 351 patients and evaluated safety and effectiveness
of the ImageReady System for use in patients with a single or dual
chamber pacemaker when used in an MRI environment.
"As shown in the SAMURAI trial, the ImageReady System gives
physicians reassurance that they are implanting pacemakers that are
safe in an MRI environment should their patients need scans in the
future," said Ronald D. Berger,
M.D., Ph.D., principal investigator of the SAMURAI trial and
professor of medicine and biomedical engineering at Johns Hopkins
Medical Institutions. "The study demonstrated the INGEVITY MRI
leads had no MR-related complications and very low rates of
complications overall."
The ImageReady System offers automatic daily monitoring via the
LATITUDE™ NXT Patient Management System. An increasingly important
tool for physicians, automatic daily monitoring has been shown to
improve survival in patients with pacemakers1. The
LATITUDE NXT wireless system allows for earlier intervention and
improved patient outcomes by providing physicians with device and
patient information through customizable alerts.
"With a pacing system specifically designed with automatic
remote monitoring that also allows patients to undergo MR scans, we
are further advancing the quality of patient care," said
Kenneth Stein, M.D., chief medical
officer, Rhythm Management, Boston Scientific. "We believe that the
daily monitoring capability of the ImageReady System, coupled with
advanced diagnostics, will help physicians identify concerns and
ultimately initiate patient care sooner."
The company is also actively pursuing MRI compatibility for
their currently approved implanted cardiac defibrillation (ICD) and
cardiac resynchronization therapy (CRT) systems via the global
ENABLE MRI study, which was initiated earlier this year. Trial
findings will be submitted to regulatory agencies in Asia and the U.S., when the company requests
updated labeling for MR-conditional use on ICD and CRT systems,
including those that have been previously implanted.
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
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
1 Varma N, Piccini JP, Snell J, Fischer A, Dalal N,
Mittal S. "The Relationship Between Level of Adherence to Automatic
Wireless Remote Monitoring and Survival in Pacemaker and
Defibrillator Patients." J Am Coll Cardiol. 2015 Jun 23;
65(24):2601-10.
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SOURCE Boston Scientific