MARLBOROUGH, Mass.,
Feb. 8, 2016 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) announced the Centers for
Medicare and Medicaid Services (CMS) will cover percutaneous left
atrial appendage closure (LAAC) therapy under specific criteria, as
outlined in the agency's final National Coverage Determination
(NCD). This decision, effective immediately, provides consistent
and uniform access to the WATCHMAN™ LAAC Device as a
non-pharmacological treatment option for stroke risk reduction for
appropriate Medicare beneficiaries.
"We are very pleased CMS has established national coverage for
this life-changing therapy for Medicare beneficiaries who have a
reason to seek an alternative to long-term anticoagulation," said
Mike Mahoney, president and chief
executive officer, Boston Scientific. "The final decision reflects
more than a decade of robust clinical evidence and will facilitate
additional data collection via a prospective national
registry."
The WATCHMAN Device, the first and only percutaneous LAAC
therapy approved by the U.S. Food and Drug Administration (FDA) in
March 2015, is indicated for patients
with non-valvular atrial fibrillation (AF) who are at high stroke
risk, suitable for warfarin, and are seeking an alternative to
long-term warfarin therapy.
According to the NCD, CMS will cover percutaneous LAAC therapy
when specific conditions are met. CMS adopted the majority of
physician and professional medical society feedback received in the
30-day public comment period, specifically as it relates to patient
coverage criteria and future data collection
requirements.
Medicare beneficiaries account for the overwhelming majority of
patients deemed candidates for the WATCHMAN Device. The remaining
population is represented by private payers. Prior to the CMS final
decision, a number of private payers, including several Blue Cross
Blue Shield plans, have updated their policies to now cover the
WATCHMAN Device.
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 percent of stroke-causing clots that come from the left
atrium in patients with non-valvular AF. Images of the WATCHMAN
Device are available at
http://www.bostonscientific.com/Watchman-Images.
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.
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 our products, CMS coverage of the
WATCHMAN Device and its impact, and markets for our products.
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
Media:
Trish Backes
651-582-5887 (office)
Boston Scientific Corporation
trish.backes@bsci.com
Investors:
Susie
Lisa
508-683-5565 (office)
Boston Scientific Corporation
investor_relations@bsci.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/boston-scientific-announces-medicare-will-cover-watchman-left-atrial-appendage-closure-device-300217012.html
SOURCE Boston Scientific Corporation