New Data on Edwards PERIMOUNT Valves Demonstrate Long-Term Durability in
Patients Aged 60 and Younger
MARSEILLE, FRANCE -- (Marketwired) -- 06/17/13 -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the science
of heart valves and hemodynamic monitoring, today announced
unprecedented long-term durability results for bovine pericardial
heart valves, based on a study of the Carpentier-Edwards PERIMOUNT
aortic valve in a subset of patients aged 60 or younger at the time
of operation. The study tracked patients over a nearly 25-year
period, achieved follow-up of 3,299 valve years and determined that
expected valve durability for this population was greater than 17
years. The data were presented Friday at the 66th Congress of the
French Society for Thoracic and Cardiovascular Surgery by Thierry
Bourguignon, M.D., from University Hospital of Tours, France.
Between July 1984 and Dec. 2008, 373 patients had aortic valve
replacement with the PERIMOUNT valve. The valve, which was introduced
into clinical use in 1981, is bio-engineered with precisely-matched
leaflets made from bovine pericardial tissue that are hand-sewn onto
a stainless steel frame. The design of the valve, including its frame
and leaflets, serves as the model upon which Edwards' leading
surgical products, Magna Ease and Magna Mitral Ease, are based.
"Pericardial valve use has increased over time. These long-term data
on the PERIMOUNT valve strengthen the evidence for surgeons to
utilize Edwards' pericardial tissue valves, including in selected
patients of age 60 and under," said Prof. Michel Aupart, M.D., head
of the Department of Cardiovascular and Thoracic Surgery, University
Hospital of Tours, France, and a paid consultant to Edwards.
At the American Association for Thoracic Surgery (AATS) Mitral
Conclave in May, Dr. Bourguignon also presented 25-year data on
patients receiving mitral valve replacement with the
Carpentier-Edwards PERIMOUNT valve, with follow-up of 3,258 valve
years. The data similarly showed that the PERIMOUNT valve had an
expected durability of more than 16 years in the mitral position, for
the entire cohort and dependent on the patient's age. The study
followed 404 consecutive patients with a mean age of 68 at the time
of their mitral valve surgery, which took place between August 1984
and March 2011. Edwards has the only tissue valve specifically
designed for the mitral position.
"More than 500,000 patients around the world have benefitted from
valve replacement with Edwards' PERIMOUNT platform, and thousands
more each year receive treatment with our market-leading surgical and
transcatheter valves," said Donald E. Bobo, Jr., Edwards' corporate
vice president, heart valve therapy. "These data offer yet another
compelling, real-world experience to validate the excellent
performance of the PERIMOUNT valve design for patients."
About Edwards Lifesciences
Edwards Lifesciences is the global leader
in the science of heart valves and hemodynamic monitoring. Driven by
a passion to help patients, the company partners with clinicians to
develop innovative technologies in the areas of structural heart
disease and critical care monitoring, enabling them to save and
enhance lives. Additional company information can be found at
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, Mr. Bobo's statements.
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 outcomes in clinical
experience or unanticipated manufacturing or quality 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, 2012.
Edwards, Edwards Lifesciences, the stylized E logo,
Carpentier-Edwards, Magna Ease, Magna Mitral Ease and PERIMOUNT are
trademarks of Edwards Lifesciences Corporation.
David K. Erickson
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