IRVINE, Calif., May 19, 2015 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE : EW ), the global leader in the science of heart valves and hemodynamic monitoring, today announced that in consultation with trial investigators, the company has voluntarily implemented a temporary pause on enrollment in its FORTIS clinical program. We observed evidence of valve thrombosis that we believe warrants additional investigation.
We are working closely with the trial investigators and Heart Teams to gather additional information in this early study of transcatheter mitral valve replacement therapy.
To date, we have treated more than 20 patients globally with the FORTIS valve, all of whom had symptomatic mitral regurgitation and who were either compassionate cases or in one of our high-risk registries. While it is still very early in the program, and we anticipated that optimizing this therapy would be challenging, we are continuing to learn which patients may benefit. We remain committed to and are encouraged by the early experience in transcatheter mitral valve replacement therapy.
The FORTIS valve is not approved for sale in any country.
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 regarding the future of transcatheter mitral replacement therapy and the temporary pause in enrollment in the FORTIS valve clinical program. 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 and in depth clinical experience and follow up, as well as other factors affecting the success of the program and of the therapy, such as unexpected developments in regulatory status or quality. 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 and FORTIS are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
SOURCE Edwards Lifesciences Corporation