Edwards Receives Approval For SAPIEN 3 Heart Valve In Canada
IRVINE, Calif., July 27, 2016 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that Health Canada has approved the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients living with severe, symptomatic aortic stenosis and at high or greater risk for surgical aortic valve replacement.
The SAPIEN 3 valve builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. The new valve is available in sizes 20mm, 23mm, 26mm and 29mm.
"The SAPIEN 3 valve has set new standards in patient outcomes and performance for heart valve replacement," said Dr. John Webb, director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia. "Supported by large, adjudicated clinical experience demonstrating extremely low rates of mortality, stroke and paravalvular leak at 30 days and 1 year, the SAPIEN 3 valve has changed the paradigm for patients in need of heart valve replacement."
The Edwards SAPIEN 3 valve has been commercially available in Europe since 2014, and received U.S. regulatory approval in 2015. The SAPIEN family of valves has been used in the treatment of more than 150,000 patients globally.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci.
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. 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 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, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, global economic conditions and customer acceptance. 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, 2015. These filings, along with important safety information about our products, may be found at Edwards.com.