TOKYO, Jan. 25 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , a global leader in hemodynamic monitoring technologies, announced that it has received regulatory and reimbursement approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for its Edwards FloTrac sensor, a minimally invasive heart monitoring device currently commercially available in the U.S. and Europe.
The FloTrac sensor provides certain key continuous cardiac measurements by accessing data directly from an arterial line, a small catheter inserted into the patient’s radial artery. Most hospitalized critically ill or surgical patients already have an arterial line in place to measure basic cardiovascular information and to draw blood, making the FloTrac sensor very easy to use. Edwards expects to launch the FloTrac sensor for commercial use in Japan in April.
“We have been working closely with the Central Social Insurance Medical Council, MHLW and some of the country’s leading physicians to bring this valuable technology to patients in Japan,” said Huimin Wang, M.D., Edwards’ corporate vice president, Japan and Intercontinental. “We are excited to be expanding this unique technology to another part of the world, where a significant number of patients can benefit,” he added.
In surgical and intensive care settings, clinicians need to monitor cardiac output, oxygen saturation levels, blood pressure and blood volume, preferably on a continuous basis. Traditionally, these critical parameters have been gathered primarily through pulmonary artery catheters that are threaded into a patient’s heart. While clinicians still rely on Edwards’ Swan-Ganz pulmonary artery catheter to obtain the most comprehensive level of cardiovascular monitoring, the FloTrac sensor recently has been used on an expanded patient population in the U.S. and Europe to less invasively gather some of those same parameters.
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, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.Edwards.com.
FloTrac is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, Edwards, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the U.S. Patent and Trademark Office.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to the ability to successfully launch the FloTrac sensor in April; the potential for FloTrac to benefit a significant number of patients; and other risks detailed in the company’s filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
Edwards Lifesciences
CONTACT: Media, Barry R. Liden, +1-949-250-5070, or investor, David K.Erickson, +1-949-250-6826, both of Edwards Lifesciences
Web site: http://www.edwards.com//
