MARLBOROUGH, Mass.,
March 24, 2015 /PRNewswire/
-- This week, three patients in the
United States received the first implants of the Boston
Scientific Corporation (NYSE: BSX) WATCHMAN™ Left Atrial
Appendage Closure (LAAC) Device. The WATCHMAN Device offers a novel
stroke risk reduction option for high-risk patients with
non-valvular atrial fibrillation (AF) who are seeking an
alternative to long-term warfarin therapy. The WATCHMAN Device
received U.S. Food and Drug Administration (FDA) approval on
Friday, March 13, 2015.
The first WATCHMAN Device procedures in the U.S. were performed
by Shephal K. Doshi, M.D., director of Cardiac Electrophysiology
and Pacing at Saint John's Health Center in Santa Monica, CA, and Saibal Kar, M.D., director of the Cardiovascular
Intervention Center Research at Cedars-Sinai Hospital in
Los Angeles, CA.
"With today's successful implantations of the WATCHMAN Device,
we are changing the way we deal with stroke risk in high-risk
patients with non-valvular atrial fibrillation," said Kar. "For
indicated patients like those who received an implant this week,
the WATCHMAN Device reduces the risk of stroke, without the need
for long-term anticoagulation therapy and its subsequent bleeding
risks."
More than five million Americans suffer from an irregular
heartbeat called non-valvular atrial fibrillation.i Many
of these patients are at increased risk of stroke, but as many as
40 percent of those patients eligible for oral anticoagulant
therapy do not take this medicationii and may need a
treatment alternative.
"As physicians, we are always looking for new therapies to
satisfy unmet patient needs," said Doshi. "There are many patients
like the ones we treated this week with the WATCHMAN Device who are
suitable for warfarin, but are not ideal candidates for chronic
anticoagulant use. These patients now have a new, proven
option to reduce their risk of AF-related stroke."
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.
"Boston Scientific is proud to work with physicians in making a
meaningful impact on patient lives by bringing left atrial
appendage closure therapy to the United
States," said Kenneth Stein,
M.D., chief medical officer, Rhythm Management, Boston
Scientific.
The WATCHMAN Device was approved by the FDA based on a robust
clinical program, which has now included more than 3,300 patients
with 6,000 patient-years of follow-up to date. The WATCHMAN
clinical program provides strong evidence that the WATCHMAN Device
can be implanted safely and reduces the risk of stroke in eligible
patients while enabling most patients to discontinue
warfarin.iii
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.iii
The WATCHMAN LAAC Device has been commercially available
internationally since 2009. It is registered in 75 countries and
more than 10,000 patients have been treated with the WATCHMAN
Device.
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.i 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.iv Twenty
percent of all strokes occur in patients with AF.v
Stroke is more severe for patients with AF, as they have a seventy
percent chance of death or permanent disability.vi
The most common treatment for stroke risk reduction in patients
with AF is blood-thinning warfarin therapy. Despite its
proven efficacy, long-term warfarin is not well-tolerated by some
patients due to a significant risk for bleeding complications, and
numerous quality-of-life tradeoffs, including dietary restrictions
and regular blood monitoring.
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% of stroke-causing clots that come from the left atrium in
people with non-valvular AF. 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.
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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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forward-looking statements include, among other things, statements
regarding our products, markets for our products, clinical trials,
and product performance and impact. If our underlying
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have affected and in the future (together with other factors) could
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CONTACTS
Media:
Trish Backes
651-582-5887 (office)
Media Relations
Boston Scientific Corporation
trish.backes@bsci.com
Investors:
Susie
Lisa
508-683-5565 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com
i Colilla S, et al. Estimates of Current and
Future Incidence and Prevalence of Atrial Fibrillation in the U.S.
Adult Population. Am J Cardiol 2013;112: 1142-1147.
ii Shah N, et al. Use of Novel Oral Anticoagulants for
Patients with Non-valvular Atrial Fibrillation: Results from the
NCDR Pinnacle Registry. J Am Coll Cardiol 2014;63(12S).
iii U.S. Food and Drug Administration. Circulatory
System Devices Panel: Boston Scientific WATCHMAN® Left Atrial
Appendage Closure Therapy (P130013). Sponsor Executive Summary
available at:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm395638.htm.
iv Holmes DR, et al. Atrial Fibrillation and Stroke
Management: Present and Future. Semin Neurol. 2010;30:
528–536.
v Hart R, et al. Atrial Fibrillation and
Thromboembolism: A Decade of Progress in Stroke Prevention. Ann
Intern Med 1999;131: 688–695.
vi Blackshear J, et al. Appendage Obliteration to Reduce
Stroke in Cardiac Surgical Patients with Atrial Fibrillation.
Ann Thorac Surg 1996;61: 755-759.
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SOURCE Boston Scientific Corporation