PARIS, May 19, 2015 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the first high-risk European patients to receive the advanced Edwards SAPIEN 3 transcatheter aortic valve via transfemoral delivery had a one-year survival rate of 91.6 percent, as well as low rates of stroke and paravalvular leak. The independently adjudicated data from the CE Mark study were presented at EuroPCR 2015 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.
Among the outcomes reported from the study, transfemoral SAPIEN 3 transcatheter aortic valve replacement (TAVR) was associated with a disabling stroke rate of 1.1 percent. In addition, only 2 percent of patients had moderate paravalvular leaks and there were no reports of severe leaks. There were also no observations of structural valve deterioration.
"The one-year survival rate in the transfemoral cohort is the highest reported in a multicenter, fully adjudicated TAVR study to date. These results set a new standard of care for patients at high risk for surgical aortic valve replacement. The results of the SAPIEN 3 trial via the transfemoral approach also raise the question of whether transcatheter valve replacement should be considered for approval for all elderly patients with severe aortic stenosis," said Webb, who served as a principal investigator in the trial.
The SAPIEN 3 Trial is a prospective, multicenter, non-randomized study. The one-year analysis documented outcomes of the first 150 patients treated with the SAPIEN 3 valve between Jan. 2013 and Nov. 2013 at 16 centers in Europe and Canada*. Access approaches included transfemoral (n=96) and transapical/transaortic (n=54), as determined by the Heart Team. At baseline, the patients in the alternative access group were significantly sicker than the transfemoral group. All-cause mortality in the alternative access group was reported as 24.3 percent in the as-treated population. The SAPIEN 3 Trial is designed to evaluate patients annually for five years.
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. 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. Dr. Webb is a consultant to Edwards Lifesciences.
* 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 atwww.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 by Dr. Webb and statements regarding patient follow-up, design features and expected product benefits and procedural outcomes of TAVR with 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 actual 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 outcomes after more expanded clinical experience and longer term follow-up, unexpected product supply, regulatory or quality developments, and changes to trends in customer experience or patient follow-up. 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, 2014.
Edwards, Edwards Lifesciences, the stylized E logo, eSheath, PARTNER, PARTNER II, Edwards SAPIEN, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.