IRVINE, Calif., June 21, 2019 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today commented on the final updated U.S.
Centers for Medicare and Medicaid Services (CMS) national coverage
determination (NCD) pertaining to transcatheter aortic valve
replacement (TAVR) programs:
"We commend CMS on its thoughtful approach toward updating the
TAVR policy. Throughout the NCD process, Edwards emphasized that
the priority must be ensuring timely patient access to high-quality
care, so that clinicians can provide all people with heart valve
disease with the therapy that is right for them. Often, the primary
risk facing severe aortic stenosis patients is not treatment
complications, but the risk of not receiving treatment at
all.
"Many of the core elements of the updated NCD better reflect
today's practices in the treatment of patients with severe AS, the
needs of those patients and the robust evidence and technology
enhancements that have occurred in the last several years. We
believe the modernized requirements and more streamlined patient
evaluation process are meaningful enhancements that may help ensure
equitable access for more patients suffering from severe AS. We are
encouraged that CMS is open to moving toward a quality measure
focused on patient outcomes, not procedural volume, in evaluating
hospitals eligible to provide TAVR in the U.S., which Edwards
believes could reasonably coincide in the future with
discontinuation of Coverage with Evidence Development. We look
forward to continuing to engage with all of the stakeholders around
the best way to ensure high quality and appropriate access for all
Medicare beneficiaries in need of treatment for structural heart
disease."
More information about the final TAVR NCD is available at
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=293&bc=AAAAAAAAACAA&.
The company is not updating or changing its financial guidance.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the
global leader in patient-focused medical innovations for structural
heart disease, as well as critical care and surgical monitoring.
Driven by a passion to help patients, the company collaborates with
the world's leading clinicians and researchers to address unmet
healthcare needs, working to improve patient outcomes and enhance
lives. For more information, visit www.Edwards.com and
follow us on Twitter @EdwardsLifesci.
This news release includes forward-looking statements within the
meaning of Section 27A of the This news release includes
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. These forward-looking statements include, but are not
limited to, statements regarding financial guidance and expected
future impacts of the National Coverage Determination, product
availability and patient access. Forward-looking statements are
based on estimates and assumptions made by management of the
company and are believed to be reasonable, though they are
inherently uncertain and difficult to predict. Our forward-looking
statements speak only as of the date on which they are made and we
do not undertake any obligation to update any forward-looking
statement to reflect events or circumstances after the date of the
statement.
Forward-looking statements involve risks and uncertainties that
could cause results to differ materially from those expressed or
implied by the forward-looking statements based on a number of
factors, including but not limited to, unexpected developments in
regulatory or reimbursement matters, or unanticipated quality,
manufacturing or regulatory issues. These factors are
detailed in the company's filings with the Securities and Exchange
Commission including its Annual Report on Form 10-K for the year
ended December 31, 2018. These
filings, along with important safety information about our
products, may be found at edwards.com.
Edwards, Edwards Lifesciences and the stylized E logo are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners. This
statement is made on behalf of Edwards Lifesciences Corporation and
its subsidiaries.
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SOURCE Edwards Lifesciences Corporation