Healthcare Industry News: transcatheter
News Release - August 21, 2013
Edwards Receives Reimbursement Approval for Sapien XT Valve in JapanIRVINE, CA--(Healthcare Sales & Marketing Network) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW) expert review panel to provide reimbursement for the Edwards SAPIEN XT transcatheter aortic heart valve. The reimbursement is scheduled to go into effect on October 1.
This decision follows regulatory approval of the SAPIEN XT valve in June. With this approval, Chuikyo established a reimbursement of 4.53 million yen (approximately $46,000 at current exchange rates) for when the SAPIEN XT valve is used in the treatment of patients with severe symptomatic aortic stenosis. The reimbursement rate for medical devices in Japan covers the cost of the device as well as taxes, certain hospital fees and distribution expenses.
"We are very pleased that the Japanese government has moved swiftly to provide reimbursement for the SAPIEN XT valve, to enable the country's clinicians to treat transcatheter aortic valve replacement patients with the latest therapy," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.
The SAPIEN XT valve is the first commercially available transcatheter valve in Japan. 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, the timing and potential impact of the reimbursement decision. 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. 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, Edwards SAPIEN, SAPIEN and Edwards SAPIEN XT are trademarks of Edwards Lifesciences Corporation.
Source: Edwards Lifesciences
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.