Edwards Lifesciences Achieves Primary Endpoint in Transcatheter Valve Study of High-Risk Surgical Patients

By Edwards Lifesciences Corporation, PRNE
Sunday, April 3, 2011

NYON, Switzerland, April 4, 2011 - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and haemodynamic monitoring, announced the results of
a pivotal clinical study of high-risk surgical patients with severe aortic
stenosis treated in Cohort A of The PARTNER Trial. These data demonstrate
that the study achieved its primary endpoint at one year, concluding that
survival of patients treated with the Edwards SAPIEN transcatheter aortic
valve was equivalent to those treated with surgical aortic valve replacement.
The data were presented at the American College of Cardiology's (ACC) 60th
Annual Scientific Session & Expo in New Orleans, LA, USA.

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In patients with aortic stenosis at high risk for surgery, transcatheter
aortic valve implantation (TAVI) was non-inferior to surgical aortic valve
replacement (AVR) for all-cause mortality at one year, 24.2 percent versus
26.8 percent, respectively. In addition, mortality at 30 days was lower than
expected in both arms of the trial, with TAVI at 3.4 percent and AVR at 6.5
percent. The observed mortality in these AVR patients was lower than the
predicted risk of operative mortality of 11.8 percent. Even with this early
generation device and limited operator experience, the TAVI mortality was the
lowest reported in any multi-centre series of clinical data for the Edwards
SAPIEN valve. (See table below for additional details.)

"We are enthusiastic that this trial clearly demonstrates the promise of
a less-invasive treatment for patients at high risk for surgery. Although
this therapy is still relatively new and rapidly evolving, it is impressive
that the patient outcomes are similar to the well-established standard of
open heart surgery," said Michael A. Mussallem, Edwards' chairman and CEO.

Both TAVI and AVR were associated with important but different
peri-procedural hazards. The study demonstrated that major vascular
complications and neurological events were more frequent with TAVI, while
major bleeding and new onset atrial fibrillation were more frequent with AVR.
Symptom improvement as measured by the New York Heart Association (NYHA)
class and six-minute walk distance favoured TAVI at 30 days and was similar
to AVR at one year.

The PARTNER Trial is the first randomised, controlled trial of a
transcatheter aortic valve. Cohort A of the trial studied 699 patients with
severe, symptomatic aortic stenosis deemed at high risk for traditional
open-heart surgery. Patients were evaluated by a multi-disciplinary team and
were evenly randomised to receive either the Edwards SAPIEN valve with
transfemoral or transapical delivery or traditional open heart surgery.

Consistent with earlier plans, Edwards expects to submit the data from
Cohort A of The PARTNER Trial to the United States Food and Drug
Administration (FDA) in the second quarter. Results from the inoperable
Cohort B of the trial also met the primary endpoints and were published in
The New England Journal of Medicine. These data are currently under review by
the FDA. Edwards continues to anticipate approval from FDA later this year
for the treatment of inoperable patients.

                                       30-day                  1-year

    Outcome                     TAVI     AVR   p-value  TAVI     AVR  p-value
                               (n=348) (n=351)         (n=348) (n=351)
    All cause mortality - %      3.4     6.5    0.07    24.2    26.8    0.44
    Major vascular
    complications - %           11.0     3.2  <0.001    11.3     3.5  <0.001
    Neurological events - %      5.5     2.4    0.04     8.3     4.3    0.04
    Major strokes - %            3.8     2.1    0.20     5.1     2.4    0.07
    Major bleeding - %           9.3    19.5  <0.001    14.7    25.7  <0.001
    New atrial fibrillation - %  8.6    16.0  <0.001    12.1    17.1    0.07

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves
and haemodynamic 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 that enable
them to save and enhance lives. Additional company information can be found
at www.edwards.com.

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. Mussallem's comments and statements regarding FDA
submissions and anticipated FDA approvals. 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 actual results or experience 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 delays in the FDA submission or
approval processes, market developments, and expanded clinical experience.
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, 2010.

Edwards, Edwards Lifesciences, the stylised E logo, Edwards SAPIEN and
PARTNER are trademarks of Edwards Lifesciences Corporation.

Media Contact: Michael George, +41(22)787-4304

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