SAN FRANCISCO, CA, November 10, 2011 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced two-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards SAPIEN transcatheter heart valve, which was approved last week by the United States Food and Drug Administration (FDA). These data from The PARTNER Trial (Cohort B) demonstrated a widening survival benefit for SAPIEN valve patients at two years, including significantly less time spent in the hospital. The new results were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
At one year, all-cause mortality was 30.7 percent for transcatheter aortic valve replacement (TAVR) and 50.7 percent for standard therapy as published last year in The New England Journal of Medicine. At two years, mortality for patients treated with TAVR remained superior to standard therapy, with the mortality curves diverging further to demonstrate rates of 43.3 percent versus 67.6 percent, respectively. There was a higher neurologic event rate in the transcatheter group as compared to standard therapy.
"The mortality advantage grew significantly at two years. Remarkably, the median days alive outside of the hospital was 699 days in TAVR patients and 355 days for standard therapy patients -- a difference of nearly one year. This demonstrates that without the SAPIEN valve, patients that survived spent significantly more time in the hospital," said Raj Makkar, M.D., associate director of the Cedars-Sinai Heart Institute.
In addition to the clinical advantages, the new data demonstrated that the improvement in hemodynamic performance was sustained at two years.
"We continue to be very pleased with the positive outcomes observed in patients treated with the transcatheter valve, who previously have not had a definitive treatment option available to them. These new data are particularly meaningful at this time, given the recent FDA approval for the SAPIEN valve," said Michael A. Mussallem, Edwards' chairman and CEO.
This trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery. Patients were evenly randomized to receive either the Edwards SAPIEN valve or standard therapy.
[Editor's note: A second press release detailing results from the quality of life and cost effectiveness analyses of The PARTNER Trial (Cohort A) will follow later today. A copy of the slides from today's TCT presentation on The PARTNER Trial data (Cohort B) are available on TCTMD.com.]
1. Hospitalization data in this press release are based on median days alive outside of the hospital.
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 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, comments made by Mr. Mussallem and Dr. Makkar. 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 market developments or changes to market expectations and results of longer term 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 stylized E logo, Edwards SAPIEN and PARTNER are trademarks of Edwards Lifesciences Corporation.
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