MARLBOROUGH, Mass.,
Aug. 2, 2018 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) announced it has
recently closed its acquisition of Claret Medical, Inc., a
privately-held company that has developed and commercialized the
Sentinel® Cerebral Embolic Protection System, the only
device cleared to protect patients against the risk of stroke in
transcatheter aortic valve replacement (TAVR) procedures.
The company also announced that the U.S. Centers for Medicare
and Medicaid Services (CMS) granted a New Technology Add-on Payment
(NTAP) designation for the Sentinel System as part of the federal
fiscal year 2019 Inpatient Prospective Payment System (IPPS). The
NTAP designation, awarded to new medical devices determined to
substantially improve the diagnosis or treatment of Medicare
beneficiaries, will be effective on October
1, 2018.
"The Sentinel System is an exciting platform technology designed
to reduce the risk of procedure-related stroke in TAVR and other
left-heart and endovascular procedures, and is an increasingly
important consideration for patients and physicians as the TAVR
indication expands to treat a younger patient population,"
said Kevin Ballinger, president, Interventional Cardiology,
Boston Scientific. "The recent CMS NTAP designation underscores the
clinical value of the Sentinel System and will allow for
accelerated adoption of this adjunctive therapy amongst structural
heart centers."
The Sentinel System – which received CE Mark in 2014 and FDA
clearance in 2017 – is the only device commercially available used
to protect patients against the risk of stroke during TAVR, a
minimally-invasive procedure to replace the aortic valve in
patients with severe aortic stenosis. Embolic debris such as
calcium or tissue can break loose during the procedure, travel
through the bloodstream towards the brain and potentially cause
neurological and neurocognitive damage. Recent studies have
estimated approximately four percent of patients experience a
clinically-apparent stroke within 30 days of a TAVR
procedure.1,2,3,4,5,6 The landmark SENTINEL
trial, which led to regulatory clearance, demonstrated that the
Sentinel System reduced the incidence of strokes by 63 percent
within the first 72 hours of the
procedure.7
Boston Scientific announced a definitive agreement to acquire
Claret Medical on July 20, 2018
for $220 million in up-front cash with an additional
$50 million payment for reaching a
reimbursement-based milestone, which has been fulfilled with the
recent NTAP designation.
1 Leon, et al., N Engl J Med. 2010;363:1597-1607.
2 Webb, et al., J Am Coll Cardiol Intv.
2015;8:1797-1806.
3 Smith, et al., N Engl J Med. 2011;364:2187-98.
4 Leon, et al., N Engl J Med 2016;374:1609-20.
5 Popma, et al., J Am Coll Cardiol 2014;63:1972-81.
6 Adams, et al., N Engl
J Med 2014;370:1790-98.
7 Kapadia S, et al. JACC. Jan
2017; 69(4): 367-377.
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 the acquisition,
the financial and business impact of the transaction, product
launches 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; the
closing and integration of acquisitions; 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.
Use of Non-GAAP Financial Measures
To supplement our
consolidated financial statements presented on a GAAP basis, we
disclose certain non-GAAP financial measures, including adjusted
net income and adjusted net income (earnings) per share that
excludes certain charges and/or credits, such as amortization
expense and acquisition-related net charges (credits). These
non-GAAP financial measures are not in accordance with generally
accepted accounting principles in the
United States and should not be considered in isolation from
or as a replacement for the most directly comparable GAAP financial
measures. Further, other companies may calculate these non-GAAP
financial measures differently than we do, which may limit the
usefulness of those measures for comparative purposes. For further
information regarding our non-GAAP measures, see Part II, Item 7 -
Management's Discussion and Analysis of Financial Condition and
Results of Operations in our most recent Annual Report on Form
10-K, which we may update in Quarterly Reports on Form 10-Q we have
filed or will file hereafter.
CONTACTS:
Trish Backes
Media Relations
(651) 582-5887 (office)
trish.backes@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
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SOURCE Boston Scientific Corporation