Healthcare Industry News: U.S. Food and Drug Administration
News Release - March 19, 2018
Edwards' Acumen Hypotension Prediction Index Launches In The U.S.IRVINE, Calif., March 19, 2018 -- (Healthcare Sales & Marketing Network) -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the U.S. Food and Drug Administration granted the De Novo request for Edwards' Acumen Hypotension Prediction Index (HPI) software. The company will initiate a targeted launch of this first-of-its-kind technology that leverages predictive analytics to alert clinicians to address potential hypotension, or low blood pressure, before it occurs in their surgical patients.
"Even brief periods of hypotension are associated with complications or, worse, death after surgery," said Maxime Cannesson, MD, PhD, Professor and Vice Chair, Department of Anesthesiology and Perioperative Medicine, at UCLA. "As blood pressure during surgery decreases, mortality increases. A software that enables clinicians to detect and address potentially developing hypotensive events before they occur is a major and unique advancement in improving patient care."
Designated as an adjunctive predictive cardiovascular indicator by FDA, the Acumen HPI feature uses software algorithms to analyze cardiovascular vital signs and predict a patient's future cardiovascular status or events. The Acumen HPI feature is only compatible with Edwards' minimally invasive, hemodynamic monitoring solutions, and comprises three elements:
- The Hypotension Prediction Index, a data driven model developed from more than 200,000 patient events that indicates the likelihood of a hypotensive event before it occurs;
- An alarm that alerts clinicians when the Hypotension Prediction Index exceeds an upper threshold;
- And a secondary screen that visually links blood pressure with hemodynamic flow parameters, providing a comprehensive view of the patient's hemodynamics to identify the root cause of the low blood pressure.
The HPI feature has CE Mark in Europe. Part of the Edwards Acumen intelligent decision-support software suite, this feature is unlocked by the minimally invasive FloTrac IQ sensor.
Dr. Cannesson 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 www.edwards.com 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. Cannesson and Ms. Szyman and expectations regarding the product's potential benefits. 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 www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Acumen, FloTrac, FloTrac IQ, HPI, and Hypotension Prediction Index are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
Source: Edwards Lifesciences
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