IRVINE, CA -- (Marketwired) -- 01/13/14 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a single-arm, non-randomized clinical trial of the SAPIEN 3 transcatheter aortic heart valve in the treatment of intermediate risk patients with severe symptomatic aortic stenosis. The company also completed enrollment in its U.S. clinical trial studying the SAPIEN 3 valve in the treatment of high-risk or inoperable patients.
The SAPIEN 3 valve is the only transcatheter heart valve available to U.S. patients that can be delivered through a low-profile 14-French expandable sheath (eSheath). It also has an outer skirt -- a cuff of fabric surrounding the bottom of the frame -- to provide a seal to address paravalvular leak. The SAPIEN 3 valve can be implanted with the transfemoral approach through an incision in the leg, as well as alternative access approaches. It is an investigational device that is not available commercially in any country; CE Mark approval in Europe is anticipated in the near future.
The new U.S. trial of the SAPIEN 3 valve will enroll up to 1,000 patients with a Society of Thoracic Surgeons score of four to eight percent, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a SAPIEN 3 valve.
"The SAPIEN 3 valve is a significant advancement, and we're excited to make progress toward bringing this sought-after transcatheter therapy to U.S. patients. It represents a big step toward fulfilling the promise of a simpler procedure with fewer complications and faster patient recovery," said Larry L. Wood, corporate vice president, transcatheter heart valves. "Last year, we completed enrollment in the first U.S. randomized controlled trial involving intermediate risk patients with severe aortic stenosis. This unique dataset of 2,000 patients receiving surgery or transcatheter valve replacement will provide a thorough baseline comparison for this new study of the SAPIEN 3 valve in intermediate risk patients."
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, statements regarding the expected timing of CE Mark approval for SAPIEN 3, and statements regarding expected outcomes of the clinical trial and anticipated benefits of SAPIEN 3. 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 the clinical trial, unanticipated outcomes of the trial or longer term clinical experience with the product, or unanticipated quality 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, 2012.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN 3 and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation.