MARLBOROUGH, Mass.,
Nov. 19, 2015 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) today announced that the first implants of
the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)
Device – the latest generation of the WATCHMAN Device – occurred in
Europe following CE mark
approval.
"The WATCHMAN Device is the most studied left atrial appendage
closure device and has been used to help reduce the risk of stroke
for tens of thousands of high-risk patients with non-valvular
atrial fibrillation who seek an alternative to long-term
anticoagulant therapy," said Dr. Kenneth
Stein, chief medical officer, Rhythm Management, Boston
Scientific. "We are pleased that this next-generation technology
has been granted European regulatory approval and we can begin a
controlled product roll-out to clinicians throughout Europe."
WATCHMAN FLX Device implants were performed last week by Dr.
Horst Sievert, department head of
Cardiology and Vascular Medicine, Sankt Katharinen Hospital, in
Frankfurt, Germany; by Dr.
Vivek Reddy, director of Cardiac
Arrhythmia Services for The Mount Sinai Hospital, at Na Homolce
Hospital in Prague, Czech
Republic; and Dr. Saibal Kar,
director of Cardiovascular Intervention Center Research at
Cedars-Sinai Heart Institute, at MC Medicor in Izola, Slovenia.
"The closed-end design of the WATCHMAN FLX Device and the
ability to fully recapture and reposition this device make it a
very promising option for treating indicated patients with simple
to the most complex anatomies," said Dr. Sievert. "With nearly a
decade of experience implanting the original WATCHMAN Device, it
has been exciting to see the advancements of this technology from
Boston Scientific and take part in the first implants of this
device in Europe."
The first-generation WATCHMAN Device was CE-marked in 2005 to
prevent thrombus embolization from the left atrial appendage (LAA)
and reduce the risk of life-threatening bleeding events in patients
with non-valvular atrial fibrillation (AF) who are eligible for
anticoagulation therapy, and in 2012 the CE Mark indication was
expanded to include those who have a contraindication to
anticoagulation therapy. AF affects approximately 15 million
patients worldwide and is a disorder that disrupts the ability of
the heart to beat regularly and pump blood efficiently. Patients
with AF have an increased risk of stroke due to the migration of
clots formed in the LAA.
This approval marks the second significant regulatory and
commercial milestone for the Structural Heart business of Boston
Scientific this year, following the U.S. Food and Drug
Administration (FDA) approval of the first-generation WATCHMAN
Device in March, 2015. In the U.S., 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.
Commercialization of the WATCHMAN FLX Device is currently in a
limited market release and will become more widely available to
approved EU countries in the first half of 2016. The WATCHMAN FLX
Device is not available for sale in the U.S.
About the WATCHMAN FLX LAAC Device
The WATCHMAN FLX 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,
sac-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 and the WATCHMAN FLX Device are available at
http://news.bostonscientific.com/image-gallery.
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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CONTACTS
Media:
Trish Backes
651-582-5887 (office)
Boston Scientific Corporation
trish.backes@bsci.com
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SOURCE Boston Scientific