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Edwards Receives Clearance For HemoSphere Platform With Intelligent Decision-Support Tools

IRVINE, Calif., Dec. 3, 2018 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced that the HemoSphere advanced hemodynamic monitoring platform has received U.S. Food and Drug Administration clearance for the Acumen suite of intelligent decision-support solutions. The latest HemoSphere platform is the first and only to include solutions for predictive monitoring of moderate to high-risk surgical patients, which make up the Acumen suite of intelligent decision-support solutions:

  • Acumen HPI (Hypotension Prediction Index) software, which introduces artificial intelligence (AI) to hemodynamic monitoring through a machine learning, data-driven algorithm that indicates the likelihood of a hypotensive, or low blood pressure, event before it occurs.
  • Acumen IQ sensor, a minimally-invasive sensor that enables the Acumen HPI software and automatically updates advanced hemodynamic parameters every 20 seconds.

"Combining the Swan-Ganz catheter and the FloTrac sensor with the Acumen suite and the Hypotension Prediction Index software on the HemoSphere platform presents a powerful integration of hemodynamic information," said Neal W. Fleming, M.D., Ph.D., Professor and Director of Cardiovascular and Thoracic Anesthesia, UC Davis School of Medicine. "The common interface simplifies the workplace for clinicians while providing comprehensive guidance to optimize and individualize patient care."

The addition of AI technology makes the HemoSphere platform a unique solution for advanced hemodynamic monitoring. Algorithms that make up the HPI feature are the result of accumulated experiences from more than 200,000 patient events. Linking pressure and flow parameters with predictive monitoring in one single platform provides clinicians with the level of decision support needed to respond proactively based on a patient's needs.

"With the addition of the Acumen suite, the HemoSphere platform is a cornerstone solution that integrates a range of advanced hemodynamic monitoring solutions and decision-support tools to address patient needs in a range of clinical settings," said Katie Szyman, Edwards' corporate vice president, critical care. "Moving forward, Edwards plans to continue to evolve and expand the machine learning algorithms to ensure clinical relevance in surgical and intensive care unit settings, to truly establish HemoSphere as the platform of the future." 

Dr. Fleming is a consultant to Edwards Lifesciences.

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. Fleming and Ms. Szyman and expectations regarding the potential benefits of HemoSphere, Acumen Hypotenstion Prediction Index, Swan-Ganz Pulmonary Artery Catheters, Acumen IQ and future products. 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, or regulatory developments. 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, 2017. These filings, along with important safety information about our products, may be found at

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


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Mark Wilterding
(SVP, Investor Relations)


Amy Hytowitz
(VP, Global Communications)