WASHINGTON and MARLBOROUGH, Mass., Nov. 2, 2016 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) announced initial U.S. commercial
performance results of the WATCHMAN™ Left Atrial Appendage Closure
(LAAC) Device today during a late-breaking clinical trial session
at the 28th Transcatheter Cardiovascular Therapeutics (TCT), the
annual scientific symposium of the Cardiovascular Research
Foundation, in Washington, D.C.
Data demonstrated a high rate of procedural success and low rate of
complications for the device which offers stroke risk reduction for
patients with non-valvular atrial fibrillation (AF) who are seeking
an alternative to long-term warfarin therapy. The study was also
published online today in the Journal of the American College of
Cardiology.
In advance of a formal national clinical registry becoming
available, procedural data were collected via WATCHMAN clinical
specialists during 3,822 consecutive LAAC procedures performed
between March 2015 and May 2016 by 382 operating physicians at 169 U.S.
medical centers. In this case series, there was a 95.6% implant
success rate with a median procedure time of 50 minutes.
Half of the procedures were performed by new implanting
physicians without previous experience with the device.
Nevertheless, the overall rate of complications evaluated within
these data was low at 1.63%, and compared favorably to the clinical
trial data leading to device approval, validating the rigorous
process for selecting and training new operators. Pericardial
tamponade requiring intervention was the most frequent major
procedural complication, which was seen in 1.02% of patients. In an
additional 0.29% of patients, a hemodynamically insignificant
pericardial effusion was observed that did not require
intervention. Device embolization, procedure-related stroke and
mortality rates also remained low at 0.24%, 0.08% and 0.08%,
respectively.
"The 'real-world' data collected from this study indicate high
procedural success, even with the large number of new implanting
physicians performing one-half of the procedures," said
Vivek Reddy, M.D., co-principal
investigator and director of Cardiac Arrhythmia Services for The
Mount Sinai Hospital and the Mount Sinai Health System. "More
importantly, we confirmed the safety of this therapy as evidenced
by the low rate of complications."
"This evaluation includes the largest WATCHMAN device patient
population studied to date and demonstrated low and consistent
complication rates compared to those seen in previous clinical
trials," said David R. Holmes, M.D.,
co-principal investigator and professor of medicine at Mayo Clinic
College of Medicine and a consultant in the Division of
Cardiovascular Diseases and the Department of Internal Medicine at
Mayo Clinic in Rochester,
Minnesota. "This provides important procedural insights in
the absence of an official Centers for Medicare and Medicaid
Services registry being available to collect data immediately
following device approval by the U.S. Food and Drug Administration
in March, 2015."
The formal national registry capturing data on left atrial
appendage occlusion (LAAO) procedures – the LAAO Registry,
sponsored by the American College of Cardiology – was approved in
August, 2016 by the Centers for Medicare and Medicaid Services.
Participation in the registry is a condition of coverage as
outlined in the LAAC National Coverage Determination (NCD). The NCD
was effective February 8, 2016 and
fully implemented nationwide on October 3,
2016.
For more information on the WATCHMAN Device, visit
www.watchman.com.
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:
Trish Backes
Boston Scientific Corporation
(651) 582-5887 (office)
Trish.Backes@bsci.com
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SOURCE Boston Scientific