MARLBOROUGH, Mass.,
July 21, 2020 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) announced it has
received U.S. Food and Drug Administration (FDA) approval for the
WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)
Device.
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The next-generation WATCHMAN FLX device is indicated to
reduce the risk of stroke in patients with non-valvular atrial
fibrillation (NVAF) who need an alternative to oral anticoagulation
therapy by permanently closing off the left atrial appendage – the
area of the heart where stroke-causing blood clots commonly form in
NVAF. This technology, which is built upon the most studied and
implanted LAAC device in the world, features a new, fully rounded
design that offers physicians the ability to safely enter, and
maneuver within, the left atrial appendage. It is the first LAAC
device that can be fully recaptured, repositioned and redeployed
for precise placement, and the new frame design allows for optimal
device engagement with the tissue for long-term stability and a
faster, more complete seal. The WATCHMAN FLX device is available in
broader size options than the previous generation device and can
treat a wider range of patient anatomies.
"We've been very pleased with the real-world clinical outcomes
and positive physician feedback for the WATCHMAN FLX device in
Europe and are excited to extend
availability of this next-generation technology to patients and
clinicians throughout the U.S.," said Joe
Fitzgerald, president, Interventional Cardiology, Boston
Scientific. "Our WATCHMAN technology was the first FDA-approved
LAAC device on the market and has been implanted in more than
100,000 patients worldwide, and now with the WATCHMAN FLX device,
we are taking the clinical benefits of the technology to the next
level for more patients while further differentiating our
structural heart portfolio in the U.S."
Positive 12-month results from the pivotal PINNACLE FLX
study, which evaluated the performance of the WATCHMAN FLX device
as an alternative to long-term non-vitamin K antagonist oral
anticoagulants (NOACs) and other OAC medications, were recently
presented as a late-breaking clinical trial at Heart Rhythm Society
2020 Science. The study met its primary safety and efficacy
endpoints with data demonstrating a low rate of major
procedure-related safety events (0.5% at 7 days post procedure) and
high rate of effective LAAC (100% with peri-device flow <
5mm at 12 months post procedure). Data also demonstrated a
high implant success rate of 98.8%.
"Built upon the success of the WATCHMAN platform and thousands
of patient-years of clinical research, the next-generation WATCHMAN
FLX device is designed to offer increased ease of use for
physicians and improved procedural outcomes for patients, including
reduced complication risk and healing time," said Dr. Ian Meredith, AM, global chief medical officer,
Boston Scientific. "We've set the bar high and look forward to
bringing these benefits to a wider range of U.S. patients with NVAF
who need an alternative to the bleeding risk and lifestyle
challenges associated with long-term use of blood thinners."
Additional clinical research using the WATCHMAN FLX device for
patients with NVAF will continue via enrollment in the OPTION trial
– comparing the device to oral anticoagulants in patients who also
undergo a cardiac ablation procedure – as well as in the
CHAMPION-AF trial, which will study a broader OAC-eligible patient
population in a head-to-head fashion to compare the device against
NOACs.
The company announced CE Mark for the next-generation WATCHMAN
FLX device in March 2019 and will
immediately commence a limited launch of the device in the
U.S.
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 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.
Cautionary Statement Regarding Forward-Looking Statements
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the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like
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CONTACTS:
Angela Mineo
Media Relations
(763) 955-8325 (office)
Angela.Mineo@bsci.com mailto:Rosie.Ireland@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
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SOURCE Boston Scientific Corporation