IRVINE, CA, July 13, 2011 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for its new EV1000 clinical monitoring platform. With a touch-screen monitor that displays a patient's physiologic status and user-friendly clinical targets and alerts, the EV1000 clinical platform is designed to simplify decision-making in the operating room (OR) and intensive care unit (ICU).
"I believe the key to improving patient outcomes in the OR and ICU is having continuous, real-time information about a patient's hemodynamic status at your fingertips," said Steve Woodford, M.D., Director of Intensive Care, Brisbane Waters Private Hospital. "The EV1000 clinical platform gives me the patient data that I need on one intuitive display that enables me to quickly decide the next course of treatment for my patients."
"We look forward to offering this sophisticated technology to clinicians and their patients in the U.S. and to integrating our current and expanding portfolio of catheters and sensors onto this platform," said Carlyn D. Solomon, Edwards Lifesciences' corporate vice president, critical care.
The EV1000 clinical platform has been available in Europe and Australia since November 2010 and recently won the gold award in the Critical Care and Emergency Medicine Products category at Medical Device + Diagnostic Industry Magazine's Medical Design Excellence Awards competition in New York City.
About the EV1000 Clinical Platform
Patient management using information provided by hemodynamic monitoring in the OR and ICU has been clinically proven to improve patient outcomes. It is estimated that more than four million patients globally could benefit from hemodynamic monitoring; however, this practice is very complex. To simplify the display and retrieval of hemodynamic information and expand its applicability, the EV1000 clinical platform allows patient data to be displayed on the clinician's choice of several different screens. These screens utilize color-coding and physiologic representation of the cardiovascular circulation to reflect patient status and enable decision-making. The company's FloTrac sensor, PreSep and PediaSat oximetry catheters, and TruWave disposable pressure transducer are compatible with this platform. Additional information about the EV1000 clinical platform can be found at www.edwards.com/EV1000.
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 that enable 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, statements by Dr. Woodford and Mr. Solomon. 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 those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected results following expanded clinical experience and market developments. These and other 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, 2010.
Edwards, Edwards Lifesciences, the stylized E logo, EV1000, FloTrac, PediaSat, PreSep, and TruWave are trademarks of Edwards Lifesciences Corporation.
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