Internacional (Marketwired, 05 de Agosto de 2013) Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards SAPIEN 3 transcatheter aortic heart valve and accessories.The trial will study the SAPIEN 3 valve in the treatment of high-risk and inoperable patients with severe symptomatic aortic stenosis. It will enroll up to 500 patients treated with one of three delivery techniques: the transfemoral approach through an incision in the leg, the transapical route between the ribs or the transaortic approach through a small incision in the chest and aorta. Edwards anticipates that the trial will have a one-year composite endpoint compared to previous SAPIEN valves.
"We're very excited to have the opportunity to initiate a U.S. study of the SAPIEN 3 valve. This valve builds on the SAPIEN platform and provides new features designed to benefit patients and enhance ease of use, such as a lower profile, a fabric cuff intended to reduce paravalvular leak and new delivery systems," said Larry L. Wood, corporate vice president, transcatheter heart valves. "We appreciate the FDA's efforts to allow initiation of this trial in a timely way, providing U.S. patients with access to our most advanced transcatheter system."
The Edwards SAPIEN 3 valve is an investigational device and is not available commercially in any country.
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 parameters and expected outcomes of the clinical trial. 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 in the clinical trial, unanticipated outcomes of, or changes to, the trial, or 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, Edwards SAPIEN, SAPIEN, Edwards SAPIEN 3 and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation.
David K. Erickson