SOURCE: Edwards Lifesciences

Edwards Lifesciences

November 07, 2011 09:00 ET

Edwards Receives FDA Approval to Expand U.S. Clinical Trial of Next-Generation Transcatheter Valve

IRVINE, CA--(Marketwire - Nov 7, 2011) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the U.S. Food and Drug Administration (FDA) conditionally approved the addition of a second treatment group to The PARTNER II Trial, which is studying the company's next-generation Edwards SAPIEN XT transcatheter heart valve.

This new cohort (Cohort A) of The PARTNER II Trial is a non-inferiority study of up to 2,000 patients with severe, symptomatic aortic valve stenosis who have an elevated risk for traditional open-heart surgery (Society of Thoracic Surgeons score >4), which is a lower risk profile than those who were enrolled in The PARTNER Trial. Patients will be evenly randomized to receive the Edwards SAPIEN XT valve or surgery. Those undergoing transcatheter valve replacement will be treated either transfemorally (via the femoral artery) or transapically (via a small incision between the ribs). The primary endpoint to be evaluated is a composite of death and major stroke at two years, with secondary endpoints that include valve performance and quality-of-life indicators.

"Based on the favorable outcomes in The PARTNER Trial, we are pleased to be able to study our next-generation valve platform in an expanded patient population that can benefit from a less-invasive therapy," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "The success of this trial would support the use of the transcatheter therapy in a broader group of patients."

Edwards hopes to complete enrollment in the first cohort (Cohort B) of this trial around year-end. Data from this cohort of inoperable patients is intended to support U.S. commercial approval of the Edwards SAPIEN XT valve.

The Edwards SAPIEN XT valve is commercially available in Europe, where it received a CE Mark in March 2010. The Edwards SAPIEN XT transcatheter valve is an investigational device in the U.S. and is not yet available commercially.

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

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 of Mr. Wood and statements regarding the timing, progress and potential outcomes of clinical studies relating to the company's transcatheter valve technologies. 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 clinical trial enrollments, changes in regulatory requirements or trial outcomes. 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 and Edwards SAPIEN XT are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo and PARTNER are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

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