MARLBOROUGH, Mass.,
May 8, 2020 /PRNewswire/ -- Today,
Boston Scientific (NYSE: BSX) announced positive 12-month results
from the PINNACLE FLX clinical trial assessing the safety and
efficacy of the next-generation WATCHMAN FLX™ Left Atrial Appendage
Closure (LAAC) Device for patients with non-valvular atrial
fibrillation (NVAF). Presented as a late-breaking clinical trial at
HRS 2020 SCIENCE, the study evaluated performance of the WATCHMAN
FLX device as an alternative to oral anticoagulation therapy,
including non-vitamin K antagonist oral anticoagulants (NOACs), for
stroke risk reduction in patients with NVAF.
The prospective, non-randomized PINNACLE FLX trial included 400
patients in the U.S. with NVAF who were eligible for
anti-coagulation therapy to reduce the risk of stroke but had an
appropriate rationale to seek a non-pharmaceutical alternative. The
trial met its primary safety endpoint – defined as occurrence of a
major procedure-related complication within 7 days following the
procedure or time of hospital discharge, whichever was later – with
a low adverse event rate of 0.5%. The study also met its primary
effectiveness endpoint, with data demonstrating a 100% rate of
effective LAA closure at 12 months post-procedure with peri-device
flow < 5mm.
"We believe the next-generation WATCHMAN FLX technology
contributed to the excellent overall clinical performance seen in
this study, notably the very low rate of safety events and high
rate of effective closure," said Shephal Doshi, M.D., study
co-principal investigator and cardiologist at Pacific Heart
Institute at Providence St. John's Health Center, California. "In fact, we saw that 90 percent
of patients showed absolutely no detectable leakage around the
device at their 12-month follow up, which compares favorably to the
rates of peri-device flow observed in the PROTECT-AF and PREVAIL
trials with the predicate WATCHMAN device and may translate into
improved long-term clinical outcomes."
Data from the trial also demonstrated an implant success rate of
98.8% and that no patients experienced peri-procedural death,
device embolization or pericardial effusion requiring cardiac
surgery, all of which is favorable in the context of previous
clinical studies.1 In addition, 96.2% of patients
were able to discontinue oral anticoagulation following their
45-day follow up. Secondary endpoints from the PINNACLE FLX study,
including the occurrence of ischemic stroke or systemic embolism,
will be reported after 24 months of patient follow-up.
"As we have seen in previous clinical trials, WATCHMAN
technology is well-established as a safe and effective therapeutic
option for patients with NVAF at increased risk for stroke and
systemic embolism who need an alternative to a lifetime on
anti-coagulant medications," said Dr. Ian Meredith, AM, global chief medical officer,
Boston Scientific. "We are pleased with the performance exhibited
by the next-generation WATCHMAN FLX device in the PINNACLE FLX
study, which mirrors positive European physician experience to date
and underscores our commitment to advancing this technology for
safe treatment of a broader population of eligible patients with
NVAF."
The next-generation WATCHMAN FLX device received CE Mark in
March 2019 and is designed to advance
procedural performance and safety while expanding the treatable
population of patients with NVAF. The new frame allows for optimal
device engagement with the tissue for long-term stability and a
faster, complete seal of the LAA. Its fully rounded design also
offers physicians the ability to safely enter, and maneuver within,
the LAA and to fully recapture, reposition and redeploy the device
during the procedure. The WATCHMAN FLX device is available in
broader size options to treat a wide range of patient
anatomies.
The company plans to further evaluate the WATCHMAN FLX device
for patients with NVAF via continued enrollment in the ongoing
OPTION trial – comparing the device to oral anticoagulants in
patients who also undergo a cardiac ablation procedure – as well as
in the CHAMPION-AF clinical trial, which will study a broader
anticoagulant-eligible patient population to evaluate the device
against NOACs for embolic stroke prevention.
For more information on the WATCHMAN device, visit
www.watchman.com.
*The WATCHMAN FLX LAAC Device is an investigational device in
the U.S. and not available for sale.
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 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,"
"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, clinical trials 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:
Angela Mineo
Media Relations
(412) 491-9713 (mobile)
Angela.mineo@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
1 Reddy VY, Holmes DR, et al. JACC 2017; 69(3):
253-261.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/pinnacle-flx-study-of-the-watchman-flx-left-atrial-appendage-closure-device-presented-as-late-breaking-clinical-trial-at-hrs-2020-science-301055760.html
SOURCE Boston Scientific Corporation