SAN FRANCISCO, CA -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, announced that preliminary results from The PARTNER II Trial demonstrated similar one-year outcomes in mortality and major clinical events between the Edwards SAPIEN XT transcatheter aortic valve and the Edwards SAPIEN valve, yet fewer vascular events with the lower-profile SAPIEN XT valve. These data from The PARTNER II Trial studying transcatheter aortic valve replacement (TAVR) in inoperable patients with severe, symptomatic aortic stenosis were presented today as a late-breaking clinical trial at the American College of Cardiology's (ACC) 62nd Annual Scientific Session in San Francisco.

"We are very pleased to see improved outcomes in both the SAPIEN and SAPIEN XT patients, as compared to results from earlier trials," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "The SAPIEN XT valve was designed to reduce complications of the TAVR procedure, and we believe this has been demonstrated by today's results. Edwards is proud to lead the advancement of cutting-edge innovations for these high-risk patients, supported by rigorous clinical evidence."

The PARTNER II Trial enrolled 560 patients deemed inoperable for traditional open-heart surgery at 28 hospitals in the United States between April 2011 and February 2012. Patients were randomized to receive one of the two Edwards transcatheter aortic heart valves: 276 received the SAPIEN valve, and 284 received the SAPIEN XT valve.

The FDA approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. The SAPIEN XT valve is an investigational device not yet available commercially in the United States.

Edwards anticipates submitting data from the inoperable cohort (Cohort B) of The PARTNER II Trial to the United States Food and Drug Administration (FDA) in the second quarter. The company expects to complete enrollment in the intermediate risk cohort (Cohort A) of The PARTNER II Trial mid-year.

The PARTNER II Trial, Inoperable Cohort (Cohort B) (i)

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                                     30-day                  1-year
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Outcome                      SAPIEN                  SAPIEN
                               XT    SAPIEN  p value   XT    SAPIEN  p value
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All-cause mortality - %        3.5     5.1    0.36    22.5    23.7    0.706
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Stroke: all - %                4.3     4.1    0.88     5.9     5.7    0.935
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Vascular events: major - %     9.6    15.5    0.04
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Vascular events: minor - %     5.0     7.4    0.23
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Background Information on The PARTNER Trial, Inoperable Cohort (Cohort B)

The PARTNER Trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery, and enrolled between April 2007 and March 2009. Patients were evenly randomized to receive either the Edwards SAPIEN valve or standard therapy. Please note that the results from The PARTNER Trial and The PARTNER II Trial are not directly comparable.

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                                  30-day                    1-year
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Outcome                          Standard                  Standard
                         SAPIEN  therapy  p value  SAPIEN  therapy  p value
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All-cause mortality - %    5.0     2.8      0.41    30.7     50.7  < 0.0001
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Stroke: all - %            6.7     1.7      0.03    10.6     4.5      0.04
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Vascular events: all - %  30.7     5.0   < 0.0001
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Source: Edwards Lifesciences