New stroke risk reduction therapy with
thromboresistant coating is designed to advance procedural
performance and safety
MARLBOROUGH, Mass., Sept. 6,
2023 /PRNewswire/ -- Boston Scientific
Corporation (NYSE: BSX) today announced it has received U.S. Food
and Drug Administration approval for the latest-generation WATCHMAN
FLX™ Pro Left Atrial Appendage Closure (LAAC) Device. Designed to
further advance the procedural performance and safety of the
WATCHMAN technology, which is indicated to reduce stroke risk in
patients with non-valvular atrial fibrillation (NVAF) who need an
alternative to oral anticoagulation therapy, the device now
features a polymer coating, visualization markers and a broader
size matrix to treat a wider range of patients.
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The WATCHMAN FLX Pro device is built upon the proven safety and
procedural performance of the WATCHMAN FLX™ LAAC device, which was
approved in July 2020 and has been
used in nearly 190,000 of the more than 300,000 WATCHMAN procedures
successfully completed to date globally. The latest WATCHMAN FLX
Pro device is enhanced with a coating designed to reduce
device-related thrombus and enable faster, controlled healing and
endothelization of the device surface. In addition, newly added
visualization markers are intended to enhance device placement for
optimal sealing around the LAA. This device is also available in a
new 40mm size option, which will enable physicians to treat a
broader range of anatomies with the WATCHMAN technology.
"We are pleased to introduce U.S. clinicians to our newest LAAC
technology, which is designed to enhance post-procedural healing,
improve the precision of WATCHMAN FLX Pro implants, and expand the
size range of treatable appendages," said Joe Fitzgerald, group president, Cardiology,
Boston Scientific. "These enhancements to our WATCHMAN FLX
technology will enable efficiency during implant procedures and
allow physicians to optimize treatment for their
patients."
Preclinical research for the new technology has shown positive
results for faster, more controlled healing around the device
surface. Data across several of these preclinical studies
demonstrated that the polymer coating provided an 86% reduction in
inflammation three days following the procedure, a 70% reduction of
thrombus at 14 days and a 50% increase in endothelial tissue
coverage 45 days post procedure.1
"There is a rich history of safe use and low thrombosis rates in
cardiovascular devices that utilize this thromboresistant polymer
coating, and we have adapted that model to provide a more
streamlined healing process that begins immediately following
LAAC," said Dr. Kenneth Stein, M.D.,
senior vice president and global chief medical officer, Boston
Scientific. "We believe this evolution of the WATCHMAN device also
gives promise for a future with less thrombosis risk, which may
eventually enable a simpler post-implant drug regimen for
patients."
The WATCHMAN FLX Pro device maintains key characteristics of the
WATCHMAN FLX device, including the fully rounded design that
enables physicians to safely enter, and maneuver within, the left
atrial appendage. It can also be fully recaptured, repositioned and
redeployed for precise placement, and the frame design allows for
optimal device engagement with the tissue for long-term stability
and a faster, more complete seal.
The WATCHMAN FLX Pro device is currently being studied in the
WATCHMAN FLX Pro CT study, a single-center premarket study using
multiple imaging modalities to assess post-procedural device tissue
coverage and the relationship, if any, to clinical outcomes. It
will also be further evaluated in the post-market HEAL-LAA study,
which will commence over the coming weeks and follow outcomes from
approximately 1,000 patients with NVAF implanted with the
technology at 60 sites in the U.S.
For more information on the WATCHMAN FLX Pro device, visit
www.watchman.com/flxpro.
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within
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
"anticipate," "expect," "project," "believe," "plan," "estimate,"
"may," "intend" and similar words. These forward-looking
statements are based on our beliefs, assumptions and estimates
using information available to us at the time and are not intended
to be guarantees of future events or performance. These
forward-looking statements include, among other things, statements
regarding our business plans, product performance and impact, new
and anticipated product approvals and launches, and clinical
trials. If our underlying assumptions turn out to be
incorrect, or if certain risks or uncertainties materialize, actual
results could vary materially from the expectations and projections
expressed or implied by our forward-looking statements. These
factors, in some cases, have affected and in the future (together
with other factors) could affect our ability to implement our
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release. As a result, readers are cautioned not to place
undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other
things: future global economic, political, competitive,
reimbursement and regulatory conditions; new product introductions;
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effect of our business strategy; and future business decisions made
by us and our competitors. All of these factors are difficult
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important risks and uncertainties that may affect our future
operations, see Part I, Item 1A – Risk Factors in our most recent
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in Quarterly Reports on Form 10-Q we have filed or will file
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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
1 Saliba et al. JACC: Clinical Electrophysiology,
May 2023.
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SOURCE Boston Scientific Corporation