MARLBOROUGH, Mass.,
Dec. 2, 2021 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) has initiated the MODULAR ATP
clinical trial to evaluate the safety, performance and
effectiveness of the mCRM™ Modular Therapy System. The mCRM System
consists of two cardiac rhythm management (CRM) devices intended to
work together to coordinate therapy: the EMBLEM™ MRI Subcutaneous
Implantable Defibrillator (S-ICD) System and the EMPOWER™ Modular
Pacing System (MPS), which is designed to be the first leadless
pacemaker capable of delivering both bradycardia pacing support and
antitachycardia pacing (ATP).
The S-ICD System is a proven treatment option for the prevention
of sudden cardiac death and, because it provides protection without
touching the heart or substernal space, eliminates many of the
complications associated with leads placed in those locations.
Recent data from the PRAETORIAN trial comparing the S-ICD to
transvenous implantable cardioverter defibrillators (TV-ICDs)
confirmed that the S-ICD – which, to date, has been implanted in
more than 100,000 patients worldwide – can be the preferred therapy
choice for the majority of ICD-indicated patients without a need
for pacing.1 Today, patients who may benefit from
receiving an S-ICD System are often implanted with a TV-ICD due to
the possibility of a future need for bradycardia pacing or ATP –
the latter of which is a therapy designed to terminate episodes of
fast, abnormal heart rates.
The EMPOWER MPS, which consists of a leadless pacemaker and
delivery catheter, is designed to complement the S-ICD System by
providing a modular option for patients who develop ATP needs in
the future, potentially expanding the patient population that can
benefit from S-ICD therapy.
"Since the EMPOWER MPS device can be delivered percutaneously
via a minimally invasive approach without the use of leads, the
mCRM System could preserve many of the benefits of the S-ICD System
while offering an option for patients who subsequently develop a
pacing requirement," said Kenneth
Stein, M.D., FACC, FHRS senior vice president and chief
medical officer, Rhythm Management and Global Health Policy, Boston
Scientific. "The components of the system are designed to work in
concert with each other, regardless of when implanted, giving
physicians the ability to provide personalized patient care today
while keeping options open in the future."
The prospective, non-randomized MODULAR ATP clinical trial will
enroll at up to 50 centers in the U.S., Canada and Europe up to 300 patients who are
guideline-indicated for an ICD or who already have an EMBLEM or
EMBLEM MRI S-ICD System implanted. The trial will evaluate the
system- and procedure-related complication-free rate of the EMPOWER
MPS, the communication success between the EMPOWER MPS and the
S-ICD System and adequate pacing capture thresholds of the EMPOWER
MPS.
The first patients in the U.S. were enrolled by Daniel J. Cantillon, M.D., FACC, FHRS, Cleveland
Clinic. Dr. Cantillon, Reinoud Knops, M.D., PhD, Department of
Cardiology, Academic Medical Centre (Amsterdam, Netherlands), Vivek Reddy, M.D., director, Cardiac Arrhythmia
Services, Mount Sinai Hospital; and Prof. Lluis Mont, M.D., PhD, FESC, Arrhythmia section
head, University of Barcelona are
serving as principal investigators of the study.
Preclinical data presented as late-breaking basic science at
American Heart Association Scientific Sessions 2021 demonstrated
that the mCRM System had excellent performance at up to 18 months,
as defined by stable communication between devices, and ability to
deliver therapy as intended.
For more information on the MODULAR ATP trial, visit
www.bostonscientific.com/mcrm. To learn more about the EMBLEM MRI
S-ICD System, visit www.sicdsystem.com.
*The EMPOWER MPS is an investigational device and limited by
U.S. law to investigational use only. It is not available for sale.
Some device references are for informational purposes only and are
pending CE Mark. Not available in the European Economic
Area.
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 40 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
(651) 582-4251 (office)
Laura.Aumann@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
1 Knops, R. E. et al. Subcutaneous or
transvenous defibrillator therapy. N. Engl. J. Med. 383, 526–536
(2020)
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SOURCE Boston Scientific Corporation