NEW ORLEANS, LA -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today 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 today at the American College of Cardiology's (ACC) 60th Annual Scientific Session & Expo in New Orleans, La.

In patients with aortic stenosis at high risk for surgery, transcatheter aortic valve replacement (TAVR) 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 TAVR 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 TAVR mortality was the lowest reported in any multi-center 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 TAVR 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 TAVR, 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 favored TAVR at 30 days and was similar to AVR at one year.

The PARTNER Trial is the first randomized, 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 randomized 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. The Edwards SAPIEN valve is an investigational device not yet available commercially in the United States.

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                                 30-day                     1-year
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                        TAVR      AVR              TAVR      AVR
       Outcome         (n=348)  (n=351)  p-value  (n=348)  (n=351)  p-value
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All cause mortality
 - %                     3.4      6.5      0.07     24.2     26.8     0.44
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Major vascular
 complications - %      11.0      3.2    < 0.001    11.3      3.5   < 0.001
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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
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Major bleeding - %       9.3      19.5   < 0.001    14.7     25.7   < 0.001
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New atrial
 fibrillation - %        8.6      16.0   < 0.001    12.1     17.1     0.07

Source: Edwards Lifesciences Corporation