MARLBOROUGH, Mass. and WASHINGTON, Oct. 30,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced the results of the primary endpoint of
the ACURATE IDE clinical trial, which evaluated the ACURATE
neo2™ Aortic Valve System in the treatment of patients with
severe, symptomatic aortic stenosis at low, intermediate, high and
extreme risk of open-heart surgery. The data were presented as a
late-breaking clinical trial at Transcatheter Cardiovascular
Therapeutics® (TCT®) 2024, the annual
scientific symposium of the Cardiovascular Research
Foundation® (CRF®).
This randomized trial evaluated the ACURATE neo2 valve,
the company's second-generation transcatheter aortic valve
replacement (TAVR) technology, versus a pre-defined control valve,
either the commercially available SAPIEN™ valve or the Evolut™
transcatheter aortic valve system, selected at the discretion of
the implanting physician. The composite rate of all-cause
mortality, stroke or rehospitalization at one year was 16.16% in
the ACURATE neo2 arm and 9.53% in the control arm, not
meeting the prespecified criterion for non-inferiority (posterior
probability for non-inferiority was 77.9%, which is lower than the
non-inferiority test threshold of 97.5%).
"This trial is the largest randomized comparison of TAVR
platforms and was conducted over four years, including during a
global pandemic that introduced complexities for enrollment," said
Michael Reardon, M.D., professor of
cardiothoracic surgery at Houston Methodist DeBakey Heart &
Vascular Center and co-principal investigator of the ACURATE IDE
trial. "These data add to the breadth of clinical knowledge of the
ACURATE valve platform and provide compelling insights on the
importance of procedural optimization that will be beneficial for
TAVR moving forward."
Also presented in the late-breaking session were data from a
post-hoc analysis to identify and evaluate expanded and
under-expanded ACURATE neo2 valve frames within the
ACURATE IDE trial. The company performed a review of key procedural
factors, including pre- and post-dilation, which helps to prepare
for, enable and confirm proper valve expansion during the
procedure. Following this review, an assessment of implant quality
for the ACURATE neo2 valve was initiated and highlighted
that approximately 20% of the valves were under-expanded. Data from
the assessment also demonstrated that the rate for death, stroke or
rehospitalization at one year was similar between the ACURATE
neo2 expanded group and the control group.
"The data presented today give clinicians a greater
understanding of the impact of procedural optimization as the TAVR
space continues to rapidly evolve," said Janar Sathananthan, M.D., chief medical officer,
Interventional Cardiology Therapies, Boston Scientific. "We believe
the findings from the ACURATE IDE post-hoc analysis and
implementation of steps to mitigate valve under-expansion may
improve outcomes for the ACURATE valve and have important
implications on other commercially available TAVR valves, and we
look forward to studying these improved techniques in future trials
of the device."
Boston Scientific continues to work closely with the U.S. Food
and Drug Administration on the regulatory strategy for approval of
the ACURATE valve platform in the U.S.
More information on the ACURATE IDE trial is available here.
*In Europe, the ACURATE neo2™ Aortic Valve System and the
ACURATE Prime™ Aortic Valve System are CE-marked. In the
USA, the ACURATE neo2
Aortic Valve System and the ACURATE Prime Aortic Valve System are
investigational devices and are restricted under federal law to
investigational use only. Not available for sale.
**Dr. Michael Reardon 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 45 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 health care. 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:
Angela Mineo
Media Relations
+1 (763) 955-8325
Angela.Mineo@bsci.com
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BSXInvestorRelations@bsci.com
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SOURCE Boston Scientific Corporation
