IRVINE, Calif., Feb. 20 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW - News) announced today that it has received a warning letter from the Los Angeles District Office of the U.S. Food and Drug Administration (FDA) resulting from an inspection of Edwards’ facility in Irvine, Calif., that concluded in August 2006. The FDA warning relates specifically to elements of the company’s quality systems, including complaint handling, documentation and quality systems training. The company does not expect this matter to have a material impact on its 2007 financial guidance. “Edwards Lifesciences has a long history of improving the lives of patients with high-quality cardiovascular technologies and we understand the integral role our quality systems play in that mission,” said Michael A. Mussallem, chairman and CEO. “We are fully committed to continual improvement of our quality systems and to resolving these issues promptly.”
Edwards has been engaged in a broad, thorough and systemic review of all of its quality systems and has kept the FDA advised of these efforts. The company also has engaged independent, external resources to assist in implementing best-in-class quality systems. The letter states that, until Edwards resolves the remaining issues in the warning letter, it will not receive premarket approvals for devices reasonably related to those issues.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company’s global brands, which are sold in nearly 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT Magna, and Swan-Ganz. 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 company’s ability to achieve 2007 financial goals and regulatory approval of new products. 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.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements 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, 2005.
Edwards and FloTrac are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.
Source: Edwards Lifesciences Corporation
