IRVINE, Calif., April 23 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation announced today that the U.S. Food and Drug Administration (FDA) has formally notified the company that Edwards’ response to the FDA’s February 2007 warning letter adequately addresses their concerns. Consequently, the FDA will not defer approval of pending pre-market submissions or export certificates for products manufactured at the company’s Irvine, Calif., facility.
“We have been very focused on promptly resolving the issues identified in the warning letter, and are pleased with the FDA’s conclusion,” said Michael A. Mussallem, chairman and CEO. “As a company dedicated to improving the lives of patients by developing high-quality cardiovascular technologies, we are committed to the continual improvement of our quality systems, and investing to make those systems best-in-class.”
The warning letter had been issued by the FDA’s Los Angeles District Office, and resulted from an inspection of Edwards’ facility in Irvine, Calif. The FDA letter related specifically to elements of the company’s quality systems, including complaint handling, documentation and quality systems training.
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 approximately 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 continually improve its quality systems. 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, 2006.
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.
Edwards Lifesciences Corporation
CONTACT: Media, Nolan D. Taira, +1-949-250-5070, or Investors, David K.Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation
Web site: http://www.edwards.com/
