MIAMI, FL -- (Marketwire) -- 10/24/12 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced three-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards SAPIEN transcatheter heart valve. The data from The PARTNER Trial (Cohort B) demonstrated a sustained and increasing survival benefit for SAPIEN valve patients at three years, as well as significantly less time spent in the hospital. The new results were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
The three-year all-cause mortality rate for transcatheter aortic valve replacement (TAVR) patients was 54.1 percent, as compared to 80.9 percent for those patients receiving standard therapy(i). Despite the advanced age and comorbidities of this inoperable patient population, the mortality rates in the third year of follow-up were 19.3 percent for TAVR patients and 40.3 percent for control. Also of note, TAVR patients experienced a median period of time out of the hospital that was more than two-and-a-half times longer than that of standard therapy patients.(ii)
There was a higher stroke rate in the transcatheter group as compared to standard therapy, although the two additional events between the second and third years of follow-up were adjudicated to not be related to the procedure or the device.
"We are very pleased that the inoperable patients in The PARTNER Trial continued to experience benefits in all the key measures of clinical outcomes. The performance and durability of the Edwards SAPIEN valve also remained excellent," said Michael A. Mussallem, Edwards' chairman and CEO. "The three-year data further highlight the devastating effects of symptomatic severe aortic stenosis in patients receiving only standard therapy -- reinforcing the important role that transcatheter valve replacement plays in the treatment of these patients."
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 SAPIEN valve or standard therapy. The United States Food and Drug Administration (FDA) approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and last week also approved SAPIEN for high-risk surgical patients.
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, statements made by Mr. Mussallem and statements regarding future potential and benefits of the Edwards SAPIEN valve. 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 the outcomes 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 unanticipated outcomes of longer-term clinical trial and commercial 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, 2011.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.
(i) All percents for mortality data in this press release are Kaplan-Meier estimates.
(ii) At three years, the median days alive out of hospital were 944 [233-1096] for TAVR, and 368 [147-1096] for standard therapy.
Sarah Huoh or Janet Kim
David K. Erickson