Another A-fib option to ask your doctor about. From the African Business Review.
http://www.africanbusinessreview.co.za/press_releases/study-of-first-in-class-watchman-device-shows-75-percent-reduction-in-stroke-risk-in-patients-with-a
Boston Scientific Corporation (NYSE: BSX) announces results from the
ASA Plavix (ASAP) Study, which studied the WATCHMAN® Left Atrial
Appendage Closure (LAAC) device. The data showed a reduction in the
risk of ischemic stroke by 75 percent in patients with atrial
fibrillation who have a contraindication to oral anticoagulants such as
warfarin. Vivek Reddy, M.D., Director of Cardiac Arrhythmia Service at Mount Sinai Medical Center in New York
and Coordinating Investigator of the study presented results today
during a late-breaking session at the Heart Rhythm Society's 33rd Annual
Scientific Sessions in Boston.
The prospective multi-center ASAP Study evaluated 150 patients with
contraindications to warfarin, who were implanted with the WATCHMAN
Device and treated with dual antiplatelet therapy for six months
post-procedure. Subjects were followed for a mean average of 14.4
months. The study employed the widely recognized CHADS2 risk
stratification score, which provides a clinical prediction tool for
estimating the risk of stroke in patients with atrial fibrillation. The
CHADS2 score has been validated by numerous studies and is regularly
used to determine whether treatment is required with anticoagulation or
antiplatelet therapy.
"WATCHMAN is the most studied LAA closure device with more than 2,000
patients enrolled in prospective studies and nearly 4,000 patient-years
of follow up," said Keith D. Dawkins,
M.D., global chief medical officer for Boston Scientific. "This novel
device has been well received in more than 30 countries where it offers a
safe and effective alternative to long-term treatment with oral
anticoagulants."
Atrial fibrillation 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 in atrial
fibrillation are at greater risk for stroke due to the migration of
clots formed in the left atrial appendage (LAA). Anticoagulants such as
warfarin have traditionally been the only therapy for reducing stroke
risk in these patients. The Boston Scientific percutaneously delivered
WATCHMAN Device is an alternative to long-term anticoagulation in
patients eligible for anticoagulant therapy. It is designed to close
the LAA, thereby preventing clots forming within the appendage and being
dislodged into the bloodstream where they can potentially cause a
stroke.
"Findings from the ASAP Study are promising in that closure of the
LAA with the WATCHMAN Device produced a significant reduction in the
expected ischemic stroke rate for this patient population," said Dr.
Reddy. "These results are very impressive and show potential for an
effective device-based solution for higher-risk patients with limited
pharmacologic options to reduce their risk of stroke."
For patients in the ASAP Study, the average baseline CHADS2 score of
2.8 equated to a predicted ischemic stroke rate of approximately 7.1
percent per year. The observed rate of ischemic stroke for patients
implanted with the WATCHMAN Device was 1.7 percent per year, a 75
percent reduction in stroke risk from the predicted stroke rate based on
the CHADS2 score (p<0.01). The corresponding upper confidence bound
yielded a stroke rate of 4.4 percent per year, lower than the predicted
stroke rate of 7.1 percent.
Stroke rates in the ASAP study were similar to those observed in the
PROTECT AF study, which assessed similar subjects not contraindicated to
warfarin. In the multi-center, randomized PROTECT AF trial, the
WATCHMAN Device proved to be non-inferior to warfarin and demonstrated a
38 percent relative risk reduction for stroke, cardiovascular death and
systemic embolism compared to long-term warfarin therapy in 707
patients.
The WATCHMAN Device was approved for marketing in Europe
and other CE Mark countries in 2009. Boston Scientific is currently
enrolling U.S. patients in the PREVAIL study, a confirmatory study
designed to gain U.S. Food and Drug Administration approval. Enrollment
is expected to be completed in the second quarter of 2012. The
WATCHMAN Device is contraindicated in patients who are not eligible for
anticoagulation therapy. In the U.S., the WATCHMAN Device is an
investigational device, limited by applicable law to investigational use
and not available for sale. The device was developed by Atritech,
which Boston Scientific acquired in March 2011. For more information,
visit www.Atritech.net.
For more news about Boston Scientific at the Heart Rhythm Society 33rd Annual Scientific Sessions, please follow us on Twitter @BostonSci.
About Boston ScientificBoston Scientific is a worldwide
developer, manufacturer and marketer of medical devices that are used in
a broad range of interventional medical specialties. For more
information, please visit: www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking StatementsThis
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 markets for
our products and launch cadence, regulatory approvals, clinical
studies, trials and outcomes, product performance and competitive
offerings. 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.
No comments:
Post a Comment