MARLBOROUGH, Mass.,
Dec. 11, 2018 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) today announced that a jury in
the United States (U.S.) District
Court for the District of Delaware
determined that the Boston Scientific U.S. patent 8,992,608 is
valid and that Edwards Lifesciences' Sapien 3™ Aortic
Valve infringes this patent and that Edwards owes Boston Scientific
infringement damages through the end of 2016. Additional damages
and interest incurred from 2017-2018 will be determined by the
court in post-trial motions.
The jury also found that the Boston Scientific LOTUS™
Aortic Valve System does not infringe Edwards' Spenser patents U.S.
7,510,575, U.S. 9,168,133, or U.S. 9,339,383.
"We continue to be encouraged by the sustained record of
positive legal rulings, first in European courts and now in the
U.S., which upholds our company's intellectual property," said
Desiree Ralls-Morrison, senior vice
president, general counsel and corporate secretary, Boston
Scientific.
The LOTUS system features an adaptive sealing technology, which
creates an external seal to prevent leakage around the valve known
as paravalvular leak or PVL, which is a proven predictor of
mortality.i,ii,iii The company anticipates the LOTUS™
Edge Valve System will be commercialized in CE mark countries in Q1
2019 and in the U.S. in mid-2019, pending FDA regulatory approval
timelines.
The LOTUS valve is one of two valve systems in the Boston
Scientific structural heart portfolio. Boston Scientific currently
offers the ACURATE neo™ Aortic Valve System in
key European markets and is also seeking a CE mark application for
the next-generation valve system, the
ACURATE neo2™, which it intends to
commercialize during the first half of
2019.
The LOTUS Edge Aortic valve system is an investigational
device in the U.S. and is not available for sale. It is pending CE
Mark.
The ACURATE neo™ and ACURATE neo2™ Aortic
Valve Systems are not available for use or sale in the
US.
The LOTUS Valve System is currently not available for use or
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 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, clinical trials, regulatory
approvals, litigation strategy 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.
i Kodali SK et al. Two-Year Outcomes after
Transcatheter or Surgical Aortic-Valve Replacement. N Engl J
Med 2012; 366:1686-1695
ii Tamburino C et al. Incidence and Predictors
of Early and Late Mortality After Transcatheter Aortic Valve
Implantation in 663 Patients With Severe Aortic Stenosis.
Circ. 2011;123:299.
iii Abdel-Wahab M et al. Aortic Regurgitation After
Transcatheter Aortic Valve Implantation: Incidence and Early
Outcome. Results from the German Transcatheter Aortic Valve
Implantation Registry.
Heart 2011;97:899-906.
CONTACTS:
Trish Backes
Media Relations
651-582-5887 (office)
Trish.Backes@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation