PARIS--(Marketwired - May 21, 2013) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that one-year data from its European post-approval study of the Edwards SAPIEN XT transcatheter aortic heart valve continued to demonstrate positive patient outcomes, including all-cause mortality and complication rates. Data from the SOURCE XT Registry documents the outcomes of 2,688 consecutively enrolled patients at 93 centers in Europe performing transcatheter aortic valve replacement (TAVR). This represents more than 20 percent of the total patients treated with SAPIEN XT valves during the time period of this study. The data were presented today at EuroPCR 2013 by Professor Stephan Windecker, M.D., chief of cardiology and director of invasive cardiology at University Hospital InselSpital Bern, Switzerland.
"We are very pleased that studies across geographies and in both real-world and clinical trial settings continue to support the benefits to patients of the lower-profile SAPIEN XT valve," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "This report from the SOURCE XT Registry confirms the positive impact TAVR provides for patients' quality of life and heart function, which is once again profound."
The SOURCE XT Registry, a monitored and adjudicated prospective registry, is studying the use of the Edwards SAPIEN XT valve in a real-world commercial setting, treating high-risk and inoperable patients with severe symptomatic aortic stenosis. The study cited both the baseline and cardiovascular characteristics of the treated patients in confirming their high risk profiles. Despite this patient risk level, the one-year survival post-TAVR was 80.5 percent(1), and freedom from important procedural complications was notable: the study found that stroke occurred in 6.3 percent of patients, and it was reported that 93.8 percent of patients had none/trace or mild paravalvular aortic regurgitation.
The presentation also addressed a segment of the treated patients with a EuroScore of less than 15 percent, which primarily consisted of patients who were deemed inoperable due to conditions such as porcelain aorta, liver disease, frailty, cancer, dialysis and severe pulmonary hypertension.
The SOURCE XT Registry enrolled patients treated with the SAPIEN XT valve in 17 countries between July 2010 and October 2011. Patients were treated using a transfemoral (62.7 percent), transapical (33.3 percent), transaortic (3.7 percent) or subclavian (.3 percent) approach and will be followed out to five years.
The Edwards SAPIEN XT valve is an investigational device not yet available commercially in the United States. It is currently being evaluated in the U.S. in The PARTNER II Trial.
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, enabling 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, Mr. Wood's comments and statements regarding clinical programs. 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 results 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 results of expanded clinical experience and unanticipated effects of regulatory, clinical and quality systems. 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, 2012.
Edwards, Edwards Lifesciences, the stylized E logo and Edwards SAPIEN XT are trademarks of Edwards Lifesciences Corporation.
(1) All percents for data in this press release are Kaplan-Meier estimates.