IRVINE, Calif., March 16, 2016 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis.
The company anticipates reimbursement approval from MHLW in the second quarter and plans to initiate a commercial launch in Japan immediately thereafter. The company expects to be fully launched in Japan by the end of the year.
“We are pleased to be able to offer Japanese clinicians and their patients access to the latest TAVR therapy with a smaller-profile transfemoral delivery system that will allow for the treatment of many patients with small or difficult-to-navigate vasculature,” said Huimin Wang, M.D., Edwards’ corporate vice president, Japan, Asia and Pacific. “We appreciate the MHLW’s progressive decision-making in allowing this device to be available to Japanese patients in a timely manner, bringing Japan alongside the U.S. and Europe.”
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 SAPIEN 3 valve, approved in 20mm, 23mm, 26mm and 29mm sizes, has an outer skirt providing a seal to address paravalvular leak. The valve can be delivered via a 14-French transfemoral eSheath introducer.
The SAPIEN 3 valve received commercial approval in Europe in January 2014 and in the U.S. in June 2015. In Japan, the SAPIEN XT valve was the first transcatheter heart valve introduced by Edwards in October 2013. The SAPIEN family of valves has been used in the treatment of more than 140,000 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, Dr. Wang’s statements and statements regarding expected timing, scope and outcomes of reimbursement decisions and the product launch, as well as statements regarding expected product features and benefits. 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 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 delays or changes in reimbursement decisions; unanticipated delays of the product launch or in outcomes following longer term clinical experience with the product; or unanticipated quality, manufacturing or regulatory delays or issues. 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.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, eSheath, SAPIEN, SAPIEN XT, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
SOURCE: Edwards Lifesciences