MARLBOROUGH, Mass.,
April 16, 2018 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) today announced that it, along
with several other opponents, successfully opposed Edwards
Lifesciences Corporation's European patent EP 2,399,550
('550) in the European Patent Office (EPO), resulting in a
revocation of the patent.
The '550 patent was the only Edwards patent that Boston
Scientific was found to infringe in the March 2017 German District Court litigation
between the companies and is also the sole basis of Edwards'
infringement action against Boston Scientific in Ireland. While Edwards has the right to appeal
the EPO's decision, Boston Scientific believes the Edwards patent
revocation will have a positive impact on both suits. As to the
Boston Scientific patents that Edwards was found to infringe in
March 2017 – EP 2 749 254 B1
('254) and EP 2 926 766 B1 ('766) – the German
Court of Appeal will hear arguments in May and June of this
year.
Following last month's U.K. Court of Appeal's decision
confirming that Edwards' Sapien 3™ device infringes the Boston
Scientific '766 patent and that all claims of that patent
are valid, the U.K. High Court has scheduled a hearing for the week
of May 14, 2018 to determine what, if
any, exception or limitation should be made to allow for Edwards to
continue to supply the Sapien 3 valve in the U.K.
Boston Scientific currently offers the ACURATE neo™
Transcatheter Aortic Valve System in key European markets. The
company is also seeking CE mark application for the next-generation
transcatheter aortic valve implantation (TAVI) system, the
ACURATE neo2™, and intends to commercialize the new
valve later this year as well as begin a pivotal clinical study for
U.S. regulatory filing.
The ACURATE family of valve products is one of two TAVI valve
systems in the Boston Scientific structural heart portfolio. The
LOTUS™ Valve System features an adaptive seal, 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 continues to have a goal to return
the LOTUS Valve to the European market and launch in the U.S. in
2019, pending its ability to clear certain technical and regulatory
hurdles.
The ACURATE neo™ Aortic Valve Systems are not available for
use or sale in the US.
The ACURATE neo2™ Aortic Valve System is not available for use
or sale.
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.
CONTACTS:
Media:
Trish Backes
Media Relations
Boston Scientific Corporation
651-582-5887 (office)
Trish.Backes@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
____________________
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.
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SOURCE Boston Scientific Corporation