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Edwards SAPIEN 3 Transcatheter Heart Valve Receives Approval In China

IRVINE, Calif., June 8, 2020 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received Chinese regulatory...

IRVINE, Calif., June 8, 2020 /PRNewswire/ -- Edwards Lifesciences Corporation (EW) - Get Edwards Lifesciences Corporation Report, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received Chinese regulatory approval for the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis (AS) at high risk for or unable to undergo open-heart surgery.

"Now, in China, patients diagnosed with severe AS have the option of a shorter procedure with excellent clinical outcomes, including a more rapid recovery than open-heart surgery," said Prof. Junbo Ge, MD, academician of the Chinese Academy of Sciences, chairman, Shanghai Institute of Cardiovascular Diseases and director, Department of Cardiology, Zhongshan Hospital, Fudan University.

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 transcatheter heart valves. The SAPIEN TAVR valves are the most widely studied transcatheter valves, with more than 30,000 patients treated in clinical trials and registries in over 65 countries around the world. The approval for high-risk and extreme-risk patients in China was supported by the China SAPIEN 3 study, which complements a highly robust set of clinical outcomes from three randomized controlled PARTNER studies, along with excellent real-world results.

"This approval marks a major milestone for Chinese physicians and their patients living with severe AS in need of alternatives to open-heart surgery," said Larry L. Wood, Edwards' corporate vice president, transcatheter aortic valve replacement. "Edwards is proud to introduce this technology, which has demonstrated successful outcomes for patients worldwide, into China. We look forward to partnering with hospitals throughout China to introduce this therapy through our comprehensive, globally proven training program."  

The valve, available in 20mm, 23mm, 26mm and 29mm sizes, is approved by the National Medical Products Administration for treating high-risk patients in China. To date, more than 650,000 patients around the world have benefitted from TAVR.

About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.

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 Prof. Ge and Mr. Wood and statements regarding expected product and program benefits and clinical outcomes. 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. Statements of past performance, efforts, or results about which inferences or assumptions may be made can also be forward-looking statements and are not indicative of future performance or results; these statements can be identified by the use of words such as "continued," "transform," "develop," "preliminary," "initial," diligence," "industry-leading," "compliant," "indications," or "early feedback" or other forms of these words or similar words or expressions or the negative thereof.  Investors are cautioned not to unduly rely on such forward-looking statements.

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 outcomes after more expanded clinical experience, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, or unexpected delays or changes in patient access, litigation or clinician acceptance. Other 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, 2019 and the Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. 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 3, SAPIEN, and SAPIEN 3, are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

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SOURCE Edwards Lifesciences Corporation