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

NYON, Switzerland, April 4, 2011 /PRNewswire/ -- 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 http://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.