SOURCE: Edwards Lifesciences

Edwards Lifesciences

May 20, 2014 08:10 ET

Excellent Early Experience Reported With Edwards SAPIEN 3 Transcatheter Valve

PARIS, FRANCE--(Marketwired - May 20, 2014) -  Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the first data on its most advanced commercially available transcatheter aortic heart valve, the Edwards SAPIEN 3 valve, were presented in a late-breaking clinical trial session at EuroPCR 2014 by John Webb, M.D., director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia.

The presentation concluded that outcomes at 30 days were excellent. Transfemoral SAPIEN 3 implantation was associated with a very low mortality of 2.1 percent, a stroke rate of 1.0 percent, and very few access-site complications. In addition, 96.6 percent of patients had ≤ mild paravalvular leak. There was no severe paravalvular leak.

"These data demonstrated that the improved valve and delivery system design allowed precise positioning of the SAPIEN 3 valve, and early outcomes from the trial clearly demonstrated outstanding safety. The results of this study indicate the SAPIEN 3 valve may enable treatment of intermediate-risk patients with aortic stenosis," said Webb, who served as a principal investigator in the trial and is a consultant to Edwards Lifesciences.

The SAPIEN 3 Trial is a prospective, multicenter, non-randomized study. This analysis documented early outcomes of the first 150 high- and intermediate-risk patients enrolled between Jan. 2013 and Nov. 2013 and treated with the SAPIEN 3 valve at 16 centers in Europe and Canada*. Access approaches included transfemoral (n=96) and transapical/transaortic (n=54), as determined by the Heart Team. All-cause mortality in all access approaches was reported as 5.3 percent in the as-treated population. The company intends for patients to be followed annually out to five years.

"The Edwards SAPIEN 3 valve sets a new standard for tissue valves, combining a low-profile design with the ability to address paravalvular leak, as well as improved delivery systems," said Larry L. Wood, corporate vice president, transcatheter heart valves. "It is particularly encouraging that these early results showed that none of the patients were re-hospitalized during the follow-up period, which is a meaningful outcome for patients who had previously been very ill."

The SAPIEN 3 valve can be delivered through a low-profile 14 French expandable sheath (eSheath). It also has an outer skirt -- a cuff of fabric that provides a seal at the bottom of the frame that is designed to reduce paravalvular aortic regurgitation.

The SAPIEN 3 valve was approved in Europe in January 2014 for the treatment of high-risk and non-operable patients with severe aortic stenosis. It is not approved for the treatment of intermediate risk patients in Europe. The 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.

All percents cited in the press release are Kaplan-Meier estimates.

* Enrollment centers are in Canada, France, Germany, Italy and United Kingdom.

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

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 by Dr. Webb and Mr. Wood and statements regarding patient follow-up, design features and expected product benefits and procedural outcomes of the Edwards SAPIEN 3 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 roll-out and benefits of the technology 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 outcomes after more expanded clinical experience and longer term follow-up, unexpected changes or delays related to product supply orregulatory or quality developments, and trends in customer 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, 2013.

Edwards, Edwards Lifesciences, the stylized E logo, eSheath, PARTNER, PARTNER II, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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