MARLBOROUGH, Mass.,
April 18, 2017 /PRNewswire/
-- Boston Scientific (NYSE: BSX) has initiated a worldwide
study that will evaluate the survival benefit of patients treated
with the EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD)
System who are aged 65 and older with a history of prior heart
attack, diabetes and moderately reduced left ventricular ejection
fraction. This subset of patients is at increased risk for sudden
cardiac arrest (SCA), but not currently considered
guideline-appropriate candidates for implantable cardiac
defibrillators.
This week, the first patient was enrolled in the Multicenter
Automatic Defibrillator Implantation Trial with Subcutaneous
Implantable Cardioverter Defibrillator (MADIT S-ICD) study by Dr.
Michael Giudici, principal
investigator and director of Arrhythmia Services at University of Iowa Hospitals and Clinics. The trial
is intended to determine if the EMBLEM MRI S-ICD System improves
survival as compared to patients remaining on their current medical
therapy. The device is a treatment option for patients at risk of
SCA that leaves the heart and vasculature untouched, thereby
reducing the risk of some complications associated with transvenous
implantable cardioverter defibrillators. Eliminating device leads
within the vasculature is particularly important for patients with
diabetes who often are at an increased risk of infection and
vascular access issues.
"Our hypothesis is that the S-ICD device may reduce all-cause
mortality in this high-risk cohort of cardiac patients with
diabetes," said Dr. Valentina
Kutyifa, principal investigator and research assistant
professor of cardiology at the University of
Rochester Medical Center. "The value of eliminating
unnecessary patient complications by implanting a defibrillator
which does not require intracardiac leads was an important factor
in our decision to utilize the S-ICD device when designing this
trial."
The prospective, randomized, multicenter MADIT S-ICD trial will
enroll up to 1,800 patients at approximately 100 sites worldwide
and is designed as one of two clinical studies piloting the
company's WIN-Her™ Initiative which aims to ensure adequate
representation of women in clinical trials. Between 2000 and 2007,
the average number of women enrolled in U.S. cardiovascular device
clinical trials was only one-third of the total study
populations.1 The WIN-Her Initiative will provide
recruiting materials customized for women participating at U.S.
sites in an effort to increase the number of female enrollees.
"In addition to the knowledge we hope to gain from this
population of patients with diabetes, we are excited for the
opportunity to improve the broad applicability of the MADIT S-ICD
trial results by increasing the enrollment of women in this study,"
said Kenneth Stein, M.D., senior
vice president and chief medical officer, Global Health Policy and
Rhythm Management, Boston Scientific. "Moreover, the trial
emphasizes our continued commitment to expanding access to all
patients who may benefit from this proven technology."
The EMBLEM MRI S-ICD System has been accepted for parallel
review for a new indication by the U.S. Food and Drug
Administration (FDA) and the Centers for Medicare & Medicaid
Services. The two organizations will concurrently review the MADIT
S-ICD trial data as well as other relevant information to determine
FDA approval and Medicare coverage of the device for patients aged
65 and older with a history of prior heart attack, diabetes and
moderately reduced left ventricular ejection fraction.
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:
Trish Backes
Media Relations
(651) 582-5887 (office)
Trish.Backes@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
investor_relations@bsci.com
1 Dhruva SS, Bero LA, Redberg RF. Gender bias in
studies for Food and Drug Administration premarket approval of
cardiovascular devices. Circ Cardiovasc Qual Outcomes.
2011;4(2):165-171.
http://circoutcomes.ahajournals.org/content/4/2/165.long.
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SOURCE Boston Scientific