Edwards Receives IDE for U.S. Clinical Trial of New Heart Valve Tissue Treatment Platform
(firmenpresse) - IRVINE, CA -- (Marketwire) -- 06/08/12 -- 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 to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve.
The single arm study will follow standard heart valve guidance and use historical controls. Heart valve trials typically enroll between 500-700 patients. The GLX technology will initially be studied on the company's market-leading Carpentier-Edwards PERIMOUNT Magna Ease Aortic Valve, and the study may be broadened to include other devices. The primary endpoints of the trial will measure valve safety and effectiveness.
"We are excited about beginning the clinical study of this unique tissue treatment platform in the U.S. with our Magna Ease valve," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "We hope that this study will be the first step towards establishing a new category of high performance heart valves treated with our GLX platform, and laying a foundation for our next generation valve technologies."
The GLX technology is a proprietary tissue treatment allowing for packaging and sterilization in a dry condition, eliminating the need to rinse the valve before implantation. The treatment is designed to provide additional protection for bovine pericardial tissue by enhancing anti-calcification, which could contribute to improved durability. The study is part of a broader development program for surgical and transcatheter heart valves, aimed at improving ease of use, facilitating less invasive procedures and simplifying device preparation.
GLX received CE Mark approval in May 2012. GLX is investigational in the U.S. and not available commercially in this country.
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 that enable them to save and enhance lives. Additional company information can be found at .
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. Bobo's statements, and statements regarding future study parameters, potential study outcomes and future development programs. 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 clinical trial timing and outcomes, results of expanded clinical experience and unanticipated impacts of regulatory decisions. 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, 2011.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, PERIMOUNT, PERIMOUNT Magna, Magna Ease and GLX are trademarks of Edwards Lifesciences Corporation.
Sarah Huoh or Janet Kim
949-250-5070
David K. Erickson
949-250-6826
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Datum: 08.06.2012 - 13:00 Uhr
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News-ID 154616
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