WATCHMAN FLX now the only LAAC technology in
the United States that allows for
either DAPT or OAC immediately following implantation
MARLBOROUGH, Mass., Sept. 6,
2022 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) has received U.S. Food and Drug Administration (FDA)
approval to expand the instructions for use labeling for the
current-generation WATCHMAN FLX™ Left Atrial Appendage Closure
(LAAC) Device to include a 45-day dual anti-platelet therapy (DAPT)
option as an alternative to 45-day oral anticoagulation (OAC) plus
aspirin for post-procedural treatment of patients with non-valvular
atrial fibrillation (NVAF).
"This revised labeling provides physicians more flexibility to
exercise their clinical judgment based on individual patient
characteristics to determine the most appropriate post-procedural
antithrombotic medication regimen," said Dr. Ian Meredith, global chief medical officer,
Boston Scientific. "This significant step forward is supported by
the robust safety and efficacy profile demonstrated by both the
legacy WATCHMAN and current-generation WATCHMAN FLX
technologies."
Clinical evidence submitted to the FDA to support the labeling
update included analyses spanning approximately 8,300 patients from
the Left Atrial Appendage Occlusion Registry (LAAO Registry) within
the American College of Cardiology Foundation's (ACCF) National
Cardiovascular Data Registry (NCDR). The data was submitted to the
FDA to support the safety and efficacy of DAPT as a post-procedural
antithrombotic regimen in patients with NVAF who may have a reason
for seeking an alternative to OAC.
The labeling in Europe has
included the choice of either OAC or a DAPT post-procedural drug
regimen for WATCHMAN technology since 2017.
Additional Recent Clinical Data Supporting the WATCHMAN FLX
Device
Recently announced real-world data for the WATCHMAN FLX device
include the results of an analysis of more than 17,000 patients
from the NCDR-LAAO Registry that demonstrated no significant
difference in rates of major adverse events at 45 days post
implant, whether patients were discharged from the hospital on
DAPT, a direct OAC and aspirin, or warfarin and aspirin.
Additionally, recently presented data from the SURPASS analysis
of more than 16,000 patients from the NCDR-LAAO Registry
demonstrated low rates of adverse events and peri-device leak
through 45 days post implant, and, in the investigator-led SEAL-FLX
study – the first study exclusively comparing the WATCHMAN FLX
device vs. the Amplatzer™ Amulet™ device – there was a
significantly higher rate of complete occlusion of the left atrial
appendage at eight weeks with the WATCHMAN FLX technology compared
to the Amulet device (72.6% vs. 30.5%), as evaluated by contrast
enhanced cardiac computed tomography (CT) imaging. This
single-center retrospective study of 300 patients also demonstrated
that the median peri-device leak area (residual flow around the
device from the LAA) was significantly smaller with the WATCHMAN
FLX device.
Ongoing studies with the WATCHMAN FLX device include the
CHAMPION-AF and OPTION clinical trials to evaluate use of the
device for broader patient populations with NVAF.
For more information on the WATCHMAN FLX device, visit
www.watchman.com/implanter.
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:
Angela
Mineo
Media Relations
(763)
955-8325
(office)
Angela.mineo@bsci.com
Lauren Tengler
Investor Relations
(508)
683-4479
BSXInvestorRelations@bsci.com
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SOURCE Boston Scientific Corporation