IRVINE, CA--(Marketwired - June 24, 2013) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards SAPIEN XT valve, making it the country's first commercially available transcatheter aortic heart valve.
The company expects to obtain reimbursement approval from MHLW by year's end, and will initiate a full launch in Japan immediately thereafter.
"We know that severe aortic stenosis is undertreated in Japan, and patients urgently need access to the latest therapy. We are pleased that Japanese regulators took a progressive approach to the approval of SAPIEN XT, focusing their review process on the valve that is the market leader in Europe, rather than our previous generation transcatheter valve," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "We are committed to a disciplined launch of this therapy, which includes a robust training program for Japanese heart teams."
In patients who are not good candidates for surgical aortic valve replacement, the Edwards SAPIEN XT valve can be implanted via a catheter into a beating heart. The device can be delivered through the transfemoral artery in the leg or transapically, through a small incision between the ribs. The valve's bovine pericardial tissue leaflets are based on Edwards' clinically proven surgical heart valves.
The Edwards SAPIEN XT valve has been studied in the treatment of thousands of patients in both commercial and clinical trial environments. The clinical study in Japan was conducted in leading cardiovascular centers Osaka University Hospital (Osaka), Sakakibara Heart Institute (Tokyo) and Kurashiki Central Hospital (Okayama).
Additionally, the valve has been used widely by clinicians throughout Europe since its commercial launch in 2010. In the United States, the SAPIEN XT valve is not commercially available; it is an investigational device being studied as part of a randomized, pivotal clinical trial.
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, Mr. Wood's statements, and statements regarding anticipated timing of reimbursement approval and full launch in Japan. 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, unanticipated delays our outcomes for reimbursement approval, as well as unexpected manufacturing, quality or regulatory 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, 2012.
Edwards, Edwards Lifesciences, the stylized E logo and Edwards SAPIEN XT are trademarks of Edwards Lifesciences Corporation.