PARIS, May 20, 2015 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that 30-day outcomes for intermediate-risk patients treated transfemorally with the SAPIEN 3 transcatheter aortic valve at centers in Europe and Canada demonstrated very low mortality and stroke rates, and no severe paravalvular leaks. These independently adjudicated data are consistent with the outcomes recently reported in a similar study of 1,000 patients treated at 51 centers in the United States. The study was presented at EuroPCR 2015 by Alec Vahanian, MD, chair of the cardiology department at Bichat University Hospital, Paris.
In the multi-center study of 101 intermediate-risk patients, all-cause mortality was 1 percent. The frequency of other important complications was also low: the disabling stroke rate was 2 percent, major vascular complications were 2 percent and the permanent pacemaker rate was 4 percent. The investigators also noted that the SAPIEN 3 valve had excellent hemodynamic performance, with very low incidence of significant paravalvular regurgitation, as only 2.3 percent of patients had moderate paravalvular leaks and there were no reports of severe leaks.
"Intermediate-risk patients treated with the Edwards SAPIEN 3 valve had remarkably low mortality at 30 days. There were very low rates of all other major complications, notably major vascular complications and new permanent pacemaker implantation," said Vahanian. "These results are meaningful since this study in multiple countries repeated the results in the large U.S. study."
The SAPIEN 3 Trial is a prospective, multicenter, non-randomized study. This analysis was designed to document the 30-day outcomes of intermediate-risk patients treated via the transfemoral approach with the SAPIEN 3 valve at 13 centers in Europe and Canada*. The SAPIEN 3 Trial is designed to evaluate patients annually for five years.
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 any country. 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. Prof. Vahanian 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 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, statements by Prof. Vahanian and statements regarding patient follow-up 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 in intermediate risk patients and longer term follow-up, unexpected developments in product supply, regulatory status or quality developments, and trends in clinical 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, 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.
SOURCE Edwards Lifesciences Corporation