MARLBOROUGH, Mass.,
March 13, 2015 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) has received U.S.
Food and Drug Administration (FDA) approval for the WATCHMAN Left
Atrial Appendage Closure Device. The WATCHMAN Device offers a new
stroke risk reduction option for high-risk patients with
non-valvular atrial fibrillation who are seeking an alternative to
long-term warfarin therapy. The WATCHMAN Device will be made
available to U.S. centers involved in our clinical studies and
additional, specialized centers as physicians are trained on the
implant procedure.
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The WATCHMAN Device is indicated to reduce the risk of
thromboembolism from the left atrial appendage in patients with
non-valvular atrial fibrillation who are at increased risk for
stroke and systemic embolism based on CHADS2 or
CHA2DS2-VASc scores, are deemed by their
physicians to be suitable for warfarin; and have an appropriate
rationale to seek a non-pharmacologic alternative to warfarin,
taking into account the safety and effectiveness of the device
compared to warfarin.
"The WATCHMAN Device is an important step forward in stroke
management for patients with AF," said Vivek Reddy, M.D., Director of the Cardiac
Arrhythmia Service at the Mount Sinai Medical Center and
co-principal investigator of the PROTECT AF and PREVAIL studies.
"We know that up to 40 percent of patients who are eligible
for oral anticoagulation do not take it for numerous
reasons1, highlighting the need for additional treatment
options. The WATCHMAN Device is a breakthrough treatment providing
those patients who are suitable for warfarin with an implant-based
alternative to long-term warfarin therapy while still reducing the
risk of stroke."
The FDA approval of the WATCHMAN Device is based on the robust
WATCHMAN clinical program which consists of numerous studies, with
more than 2,400 patients and nearly 6,000 patient-years of
follow-up. The WATCHMAN clinical program provided strong evidence
that the WATCHMAN Device can be implanted safely2 and
reduces the risk of stroke in eligible patients while enabling most
patients to discontinue warfarin3. Additionally, a
meta-analysis of all of the randomized trial data demonstrated that
while ischemic stroke reduction favored warfarin, the WATCHMAN
Device provided patients with a comparable protection against
all-cause stroke and statistically superior reductions in
hemorrhagic stroke, disabling stroke, and cardiovascular death
compared to warfarin over long-term follow-up.4
"Today marks a defining moment in the company's journey towards
establishing left atrial appendage closure therapy in the United
States. Boston Scientific is proud to offer this potentially
life-changing stroke risk treatment option to high-risk patients
with AF who have a reason to seek a non-drug alternative to
warfarin. This therapy could free them from the
challenges of long-term warfarin therapy," said Joe Fitzgerald, executive vice president and
president, Rhythm Management, Boston Scientific. "FDA
approval of the WATCHMAN Device is another example of Boston
Scientific delivering on its commitment to bring meaningful
innovations to patient care."
The WATCHMAN Device has been commercially available
internationally since 2009 and is the leading device in
percutaneous left atrial appendage closure globally. It is
registered in 75 countries and more than 10,000 patients have been
treated with the WATCHMAN Device.
Investor Event and Webcast Information
Boston
Scientific, in connection with its attendance at the 2015 American
College of Cardiology 64th Annual Scientific Session in
San Diego, CA, will host an
investor event and live webcast to discuss the WATCHMAN Device on
Sunday, March 15. The event, which will include a question
and answer session, is scheduled to begin at 1:00 p.m. PT and adjourn at approximately
2:30 p.m. PT and will be hosted by
Joe Fitzgerald, executive vice
president and president, Rhythm Management, and Kenneth Stein, M.D., senior vice president and
chief medical officer, Rhythm Management. Vivek Reddy, M.D., Director of the Cardiac
Arrhythmia Service at the Mount Sinai Medical Center will also
present.
A live webcast of the event will be available via the Boston
Scientific website. Webcast registration is available on the
Investor Relations section of the website at
www.bostonscientific.com/investors. Registration at least 15
minutes prior to the scheduled start time is encouraged to ensure a
timely connection.
A replay of the webcast will be archived and accessible at
www.bostonscientific.com/investors approximately one hour following
the completion of the conference call.
About Atrial Fibrillation and Stroke
Non-valvular
atrial fibrillation (AF) is an irregular heartbeat that can lead to
blood clots, stroke, heart failure and other heart-related
complications. AF is the most common cardiac arrhythmia,
currently affecting more than five million Americans.5
Patients with AF have a five-fold increased risk of stroke due to
blood stagnating from the improperly beating atrium and the
resulting blood clot formation.6 Twenty percent of all
strokes occur in patients with AF.7 Stroke is more
severe for patients with AF, as they have a 70 percent chance of
death or permanent disability.8
The most common treatment for stroke risk reduction in patients
with AF is blood-thinning warfarin therapy. Despite its
proven efficacy, long-term warfarin therapy is not well-tolerated
by some patients due to numerous quality-of-life tradeoffs - like
dietary restrictions and regular blood monitoring - and carries a
significant risk for bleeding complications.
About the WATCHMAN LAAC Device
The WATCHMAN LAAC
Device is a catheter-delivered heart implant designed to close the
left atrial appendage (LAA) in order to prevent the migration of
blood clots from the LAA, and thus, reduce the incidence of stroke
and systemic embolism for higher risk patients with non-valvular
AF. The LAA is a thin, sack-like appendix arising from the
heart and is believed to be the source of >90 percent of
stroke-causing clots that come from the left atrium in patients
with non-valvular AF.4 Images of the WATCHMAN Device are
available at
http://bostonscientific.mediaroom.com/image-gallery?mode=gallery&cat=1760.
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 35 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," "intend" and similar words. These forward-looking
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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 products, our business plans, product launches and
availability, clinical trials and data impact, competitive
offerings, and product performance and impact. 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 business
strategy and may cause actual results to differ materially from
those contemplated by the statements expressed in this press
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 economic, competitive, reimbursement and regulatory
conditions; new product introductions; demographic trends;
intellectual property; litigation; financial market conditions; and
future business decisions made by us and our competitors. All
of these factors are difficult or impossible to predict accurately
and many of them are beyond our control. For a further list
and description of these and other important risks and
uncertainties that may affect our future operations, see Part I,
Item 1A – Risk Factors in our most recent Annual Report on
Form 10-K filed with the Securities and Exchange Commission, which
we may update in Part II, Item 1A – Risk Factors in
Quarterly Reports on Form 10-Q we have filed or will file
hereafter. We disclaim any intention or obligation to
publicly update or revise any forward-looking statements to reflect
any change in our expectations or in events, conditions or
circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements. This cautionary
statement is applicable to all forward-looking statements contained
in this document.
CONTACTS
Media:
Nisha Deo
508-683-5571 (office)
408-893-9243 (cell)
Media Relations
Boston Scientific Corporation
Nisha.deo@bsci.com
Investors:
Susie Lisa,
CFA
508-652-5345 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com
1 NCDR Pinnacle Registry
2 PROTECT AF, CAP, PREVAIL and CAP2
3 PROTECT AF, CAP, PREVAIL
4 POOLED PROTECT AF and PREVAIL data
5 Colilla et al., Am J Cardiol. 2013; 112:1142-1147
6 Holmes DR, Seminars in Neurology 2010; 30:528–536
7 Hart RG, Halperin JL., Ann Intern Med. 1999;
131:688–695
8 Blackshear J. and Odell J., Annals of Thoracic
Surgery. 1996; 61:755-759
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SOURCE Boston Scientific Corporation