Healthcare Industry News:  Edwards Lifesciences 

Devices Cardiology Monitoring FDA

 News Release - April 19, 2017

Edwards' Advanced Hemodynamic Monitoring Platform Receives FDA Clearance

IRVINE, Calif., April 19, 2017 -- (Healthcare Sales & Marketing Network) -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, has received FDA clearance for its HemoSphere advanced monitoring platform. This technology provides clinicians with exceptional clarity on a patient's hemodynamics, or the factors that manage blood flow, to help them make proactive, timely clinical decisions. It's also a scalable platform that can be tailored to meet the needs of each patient and clinician.

"The HemoSphere advanced monitor enables simplified visual clinical support, which is particularly important in the care of our most complex, critically ill patients," said Davinder Ramsingh, MD, director of Clinical Research and Perioperative Ultrasound and associate professor, Department of Anesthesiology, Loma Linda University Medical Center. "Clinicians can choose the clinical support screens that best suit their needs and monitor the pressures and blood flow of the right heart as conditions change, informing potentially life-saving decisions on behalf of their patients."

Representing the next generation of hemodynamic monitoring, the HemoSphere advanced monitor is wireless-enabled and allows clinicians to collect a patient's hemodynamic data, which they can evaluate to improve patient care. The platform incorporates high-quality, visual clinical support screens and an intuitive touchscreen, and clinical teams can adapt the system to meet the needs of their care environment. The HemoSphere advanced monitor is currently compatible with the Edwards Swan-Ganz pulmonary artery catheter and Oximetry catheters.

"The HemoSphere advanced monitor builds on Edwards' more than 50 years of experience in providing clinicians with technology and education to help improve patient care and lays the foundation for future advancements in hemodynamic monitoring," said Catherine M. Szyman, Edwards' corporate vice president, critical care.

Hemodynamic monitoring is the measurement of blood circulation and cardiac function that allows clinicians to evaluate whether enough oxygen is being delivered to a patient's organs and tissues. Healthcare providers use this information to detect changes or problems in a patient's health, which allows for more informed, immediate treatment decisions.

The HemoSphere advanced monitor is also approved for commercial use in Europe, Japan, Australia and New Zealand.

About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit and follow us on Twitter @EdwardsLifesci.

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. Ramsingh and Ms. Szyman and expectations regarding the product's potential benefits and risks, as well as expected future innovations. 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 results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated outcomes of longer term clinical experience with the products, or unanticipated manufacturing, quality, development or regulatory delays or issues. These and other additional 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, 2016. These filings, along with important safety information about our products, may be found at

Edwards, Edwards Lifesciences, the stylized E logo, HemoSphere, Swan and Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Source: Edwards Lifesciences

Issuer of this News Release is solely responsible for its content.
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