MARLBOROUGH, Mass.,
Nov. 17, 2020 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) has announced it
has initiated a global, voluntary recall of all unused inventory of
the LOTUS Edge™ Aortic Valve System due to complexities
associated with the product delivery system. The voluntary recall
is related solely to the delivery system, as the valve continues to
achieve positive and clinically effective performance post-implant.
There is no safety issue for patients who currently have an
implanted LOTUS Edge valve.
Given the additional time and investment required to develop and
reintroduce an enhanced delivery system, the company has
chosen to retire the entire LOTUS product platform immediately. All
related commercial, clinical, research & development and
manufacturing activities will also cease.
"While we have been pleased with the benefits the LOTUS Edge
valve has provided to patients, we have been increasingly
challenged by the intricacies of the delivery system required to
allow physicians to fully reposition and recapture the valve," said
Mike Mahoney, chairman and chief
executive officer, Boston Scientific. "The complexity of the
delivery system, manufacturing challenges, the continued need for
further technical enhancements, and current market adoption rates
led us to the difficult decision to stop investing in the Lotus
Edge platform. We will instead focus our resources and efforts on
our ACURATE neo2™ Aortic Valve System,
Sentinel™ Cerebral Embolic Protection System and
other high growth areas across our portfolio."
This decision is expected to result in estimated total pre-tax
GAAP charges of approximately $225
million to $300 million due to
inventory, fixed asset, intangible asset and certain other exit
charges and approximately $100
million to $150 million of
these charges will impact the company's adjusted results. The vast
majority of these charges will be recorded during the fourth
quarter of 2020. The decision is expected to be accretive to GAAP
and adjusted earnings per share in 2021 by approximately one to
two cents and neutral thereafter.
Conference Call and Webcast Information
Boston
Scientific will be hosting a conference call for investors on
November 17, 2020 at
8:00 a.m. EST to discuss the
announcement. To participate in the conference call, please dial
(833) 685-0550 or (412) 317-5733. The live webcast and archived
replay of this call will be available at our Investor Relations
website investors.bostonscientific.com in the Events
section.
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.
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, financial performance, 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:
Trish Backes
Media Relations
651-582-5887
Trish.Backes@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565
BSXInvestorRelations@bsci.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/boston-scientific-announces-lotus-edge-aortic-valve-system-voluntary-recall-and-product-discontinuation-301174382.html
SOURCE Boston Scientific Corporation