MARLBOROUGH, Mass.,
April 23, 2019 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) today announced
it has received U.S. Food and Drug Administration (FDA) approval
for the LOTUS Edge™ Aortic Valve System. Delivered via a
minimally-invasive procedure, this transcatheter aortic valve
replacement (TAVR) technology is approved for patients with severe
aortic stenosis who are considered at high risk for surgical valve
replacement via open heart surgery.
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"Bringing the much-anticipated LOTUS Edge valve system to
market allows us to provide patients who aren't good candidates for
traditional surgery a safe and effective treatment alternative to
restore proper function to their severely narrowed aortic valve,"
said Kevin Ballinger, executive vice
president and global president, Interventional Cardiology, Boston
Scientific. "This technology is a fundamental component of our
expanding portfolio and demonstrates our continuing commitment to
category leadership within the fast-growing Structural Heart
treatment landscape."
The LOTUS Edge valve system is the only FDA-approved
aortic valve that gives physicians the option to reposition and
completely recapture the valve once it has been fully deployed. It
also features a braided valve frame and an adaptive seal that
minimizes paravalvular regurgitation or leaking (PVL) by conforming
to the patient's native aortic valve.
"We are thrilled to offer physicians in the U.S. and
Europe the clinical benefits of
the LOTUS Edge valve system for the treatment of their
high-risk patients with severe aortic stenosis," said
Professor Ian Meredith, AM, executive vice president and
global chief medical officer, Boston Scientific. "This system
provides physicians a high level of control over the delivery and
deployment of the device and offers surgical-like PVL results to
help ensure the best patient outcomes."
The FDA approval of the LOTUS Edge valve system adds to
the Boston Scientific suite of Structural Heart product solutions –
including the SENTINEL™ Cerebral Protection System and the
WATCHMAN™ Left Atrial Appendage Closure Device – available in the
U.S., as well as the ACURATE neo™ Aortic Valve System* in
Europe.
The company commenced a controlled launch of the valve system in
Europe in March and expects to begin a controlled launch
in the U.S. in the coming weeks.
For more information about the LOTUS Edge valve system,
visit bostonscientific.com/LOTUSEdge.
About Aortic Valve Disease
Aortic valve disease
results in dysfunction of the aortic valve, one of the four valves
that control the flow of blood in and out of the heart. Aortic
valve stenosis is the process of thickening and stiffening in the
valve, which can result in an abnormal narrowing of the aortic
valve opening and reduction in blood flow. Aortic stenosis is the
most common valvular heart disease in the world, affecting
approximately 7 percent of the population over age 65.1
From the onset of severe aortic stenosis symptoms, the average
survival rate is 50 percent at two years and 20 percent at five
years without aortic valve replacement.2,3
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.
*The ACURATE neo™ valve system
is not available for use or sale in the US.
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, 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;
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
(763) 955-8325 (office)
Angela.Mineo@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
1 Arora S, et al. "Transcatheter Aortic Valve
Replacement: Comprehensive Review and Present Status." Tex Heart
Inst J. 2017; 44(1):29-38.
2 Ramaraj R and V.L. Sorrell. "Degenerative Aortic
Stenosis." BMJ. 2008; 336(7643):550-555.
3 Lester, S.J. et al. CHEST 1998; 113:1109-14.
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SOURCE Boston Scientific Corporation