SOURCE: Edwards Lifesciences

Edwards Lifesciences

November 02, 2009 09:00 ET

Edwards Lifesciences and DexCom Announce Receipt of CE Mark for Glucose Monitoring System

IRVINE, CA and SAN DIEGO, CA--(Marketwire - November 2, 2009) - Edwards Lifesciences Corporation (NYSE: EW), the leader in the sciences of heart valves and hemodynamic monitoring, and DexCom, Inc. (NASDAQ: DXCM), a medical device company focused on the design, development and commercialization of continuous glucose monitoring systems, today announced the receipt of CE Mark for an automatic glucose monitoring system. Edwards and DexCom co-developed this new system, which is indicated for automatic, real-time monitoring and trending of blood glucose concentration in critically ill adults in the hospital environment. This CE Mark allows for commercialization of the system in the European Union and the countries in Asia and Latin America that recognize the CE Mark. Market evaluations of a first generation product are expected to begin in a limited number of European sites before the end of the year.

Studies have shown that hospitalized patients can be at a higher risk of infection and other complications if their blood glucose level is elevated for prolonged periods. Currently, clinicians manage patients' glucose levels by manually obtaining intermittent samples over various periods of time. Methods for obtaining blood samples can be labor intensive and may not provide complete information about a patient's glucose status. This glucose monitoring system will perform multiple automatic readings per hour that may provide a new level of trending insight designed to enable clinicians to effectively implement glycemic control.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at

About DexCom

DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for ambulatory use by patients and by healthcare providers in the hospital.

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 can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," or other similar expressions and include, but are not limited to, timing of market introduction of the system and product performance. 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 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, 2008.

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

DexCom is a trademark of DexCom, Inc.

Contact Information

  • Edwards Lifesciences

    Media Contact:
    Amanda Fowler

    Investor Contact:
    David K. Erickson


    Media/Investor Contact:
    Steven R. Pacelli