Additional data from APPRAISE ATP trial
reinforce modular therapy approach with EMBLEM™ Subcutaneous
Implantable Defibrillator and EMPOWER™ Leadless Pacemaker
MARLBOROUGH, Mass., May 18, 2024
/PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX)
today announced positive six-month results from the ongoing pivotal
MODULAR ATP clinical trial of the mCRM™ System,* the first modular
cardiac rhythm management (CRM) system that consists of the EMBLEM™
Subcutaneous Implantable Defibrillator (S-ICD) System and the
EMPOWER™ Leadless Pacemaker (LP). As components of the mCRM System,
the devices are designed to work together wirelessly to coordinate
painless intracardiac anti-tachycardia pacing (ATP) therapy,
provide rate-responsive bradycardia pacing support and to prevent
sudden cardiac death without the risk of leads in the heart or
under the sternum. Findings were presented at Heart Rhythm 2024,
the annual meeting of the Heart Rhythm Society, and simultaneously
published in The New England Journal of Medicine.
In addition to evaluating the safety and performance of the
EMPOWER LP as a standalone pacemaker, the trial evaluated the
ability of the EMBLEM S-ICD System to successfully communicate a
wireless request to the LP to deliver ATP therapy. Findings from
the trial met all pre-specified six-month safety and effectiveness
endpoints, and demonstrated:
- A major complication-free rate of 97.5% after implantation of
the EMPOWER LP.1
- A communication success rate of 98.8% from the EMBLEM S-ICD
System to the EMPOWER LP.2
- An ATP success rate of 61.3%,3 and no patient
requests for deactivation of ATP or bradycardia pacing due to pain
or discomfort.
- Pacing capture thresholds, which indicate stable device
fixation within the heart, of ≤ 2.0 V at 0.4 ms in 97.4% of
patients.
"We saw excellent overall clinical performance of the mCRM
System in this study, including a high rate of communication
success from the S-ICD to the leadless pacemaker, and a low rate of
major leadless pacemaker complications," said Prof. Reinoud Knops,
M.D., Ph.D., Department of Cardiology and Electrophysiology,
Amsterdam UMC, Amsterdam,
Netherlands. "These findings are noteworthy, as high
percentages of communication success and pain-free termination of
spontaneous arrhythmia episodes indicate a potential upgrade
pathway for patients currently implanted with an S-ICD who develop
a need for ATP or pacing."
Also presented at Heart Rhythm 2024 were results from the
APPRAISE ATP clinical trial – a prospective, randomized,
multicenter study evaluating ATP as a primary strategy for
terminating ventricular tachycardias in primary prevention (PP)
patients (i.e., those without a history of spontaneous sustained
ventricular arrhythmias). The trial enrolled 2,626 PP patients
indicated to receive an ICD at 134 centers globally and is the
largest head-to-head trial of ATP in this patient group. In the
study, patients were randomized 1:1 to standard transvenous-ICD
therapy – ATP plus an ICD-delivered shock to terminate a
ventricular tachycardia – versus shock only. Across five years of
follow up, data demonstrated a statistically significant, but small
absolute first all-cause shock reduction in only 1% of patients per
year. Shock burden, or the number of shocks experienced by a
patient, was not significantly different between the two arms, and
the vast majority of patients in the ATP-plus-shock arm did not
require ATP therapy.
"Together, data from the MODULAR ATP and APPRAISE ATP trials
reinforce the promise of the groundbreaking mCRM System,
illustrating a clear path forward for physicians to offer therapies
that prevent sudden cardiac death and deliver ATP for the small
number of patients who benefit from it," said Kenneth Stein, M.D., senior vice president and
global chief medical officer, Boston Scientific. "Instead of
subjecting all patients to the risks of more invasive approaches,
such as placing leads in the heart or tunneling them under the
sternum to provide therapies they might not require, these data
indicate physicians may have the opportunity to tailor therapy to
the patient's individual needs and health."
The company anticipates U.S. Food and Drug Administration
approval of the mCRM System in 2025. For more information on the
mCRM System and MODULAR ATP trial, visit
www.bostonscientific.com/mcrm. To learn more about the EMBLEM MRI
S-ICD System, visit www.sicdsystem.com.
*The EMPOWER LP 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.
**Dr. Reinoud Knops is a paid consultant of Boston Scientific
Corporation. He has not been compensated in connection with this
press release.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
technologies 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. Our portfolio of devices and
therapies helps physicians diagnose and treat complex
cardiovascular, respiratory, digestive, oncological, neurological
and urological diseases and conditions. Learn more at
www.bostonscientific.com and connect
on LinkedIn and X, formerly Twitter.
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CONTACTS:
Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com
Jon Monson
Investor Relations
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BSXInvestorRelations@bsci.com
1 Major complications defined as any complication
related to the EMPOWER LP or its implantation procedure that
results in system revision, permanent loss of LP function,
hospitalization, or death.
2 During communication tests, the S-ICD attempted to
command the LP to deliver pacing at a rate approximately 10 beats
per minute faster than the patient's intrinsic rhythm.
3 ATP success rate defined as terminating ventricular
arrhythmia.
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SOURCE Boston Scientific Corporation