SAN FRANCISCO, CA--(Marketwire - Mar 10, 2013) - Edwards Lifesciences Corporation (
"We are very pleased to see improved outcomes in both the SAPIEN and SAPIEN XT patients, as compared to results from earlier trials," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "The SAPIEN XT valve was designed to reduce complications of the TAVR procedure, and we believe this has been demonstrated by today's results. Edwards is proud to lead the advancement of cutting-edge innovations for these high-risk patients, supported by rigorous clinical evidence."
The PARTNER II Trial enrolled 560 patients deemed inoperable for traditional open-heart surgery at 28 hospitals in the United States between April 2011 and February 2012. Patients were randomized to receive one of the two Edwards transcatheter aortic heart valves: 276 received the SAPIEN valve, and 284 received the SAPIEN XT valve.
The FDA approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. The SAPIEN XT valve is an investigational device not yet available commercially in the United States.
Edwards anticipates submitting data from the inoperable cohort (Cohort B) of The PARTNER II Trial to the United States Food and Drug Administration (FDA) in the second quarter. The company expects to complete enrollment in the intermediate risk cohort (Cohort A) of The PARTNER II Trial mid-year.
The PARTNER II Trial, Inoperable Cohort (Cohort B) i
|Outcome||SAPIEN XT||SAPIEN||p value||SAPIEN XT||SAPIEN||p value|
|All-cause mortality - %||3.5||5.1||0.36||22.5||23.7||0.706|
|Stroke: all - %||4.3||4.1||0.88||5.9||5.7||0.935|
|Vascular events: major - %||9.6||15.5||0.04|
|Vascular events: minor - %||5.0||7.4||0.23|
Background Information on The PARTNER Trial, Inoperable Cohort (Cohort B)
The PARTNER Trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery, and enrolled between April 2007 and March 2009. Patients were evenly randomized to receive either the Edwards SAPIEN valve or standard therapy. Please note that the results from The PARTNER Trial and The PARTNER II Trial are not directly comparable.
|Outcome||SAPIEN||Standard therapy||p value||SAPIEN||Standard therapy||p value|
|All-cause mortality - %||5.0||2.8||0.41||30.7||50.7||< 0.0001|
|Stroke: all - %||6.7||1.7||0.03||10.6||4.5||0.04|
|Vascular events: all - %||30.7||5.0||< 0.0001|
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 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. Wood, statements regarding future potential and benefits of the Edwards SAPIEN XT valve and expectations regarding the timing of FDA submissions and clinical trial enrollment. 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 delays in clinical trial enrollment or regulatory submissions, or unanticipated outcomes of longer-term clinical trial or commercial experience or final adjudication of the clinical trial results. 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, Edwards SAPIEN, Edwards SAPIEN XT, PARTNER, PARTNER II, SAPIEN and SAPIEN XT are trademarks of Edwards Lifesciences Corporation.
i All percents for mortality and stroke data in this press release are Kaplan-Meier estimates.