Edwards Receives Clearance For Hypotension Prediction Index Software For Noninvasive Acumen IQ Cuff

IRVINE, Calif., June 1, 2021 -- Edwards Lifesciences (NYSE: EW) today announced that Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff has received U.S. Food and Drug Administration clearance. This is the first noninvasive solution that unlocks Acumen HPI software and uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only been available for patients using an invasive arterial line.

"Numerous studies, including our research, have demonstrated an association between intraoperative hypotension and increased risk of acute kidney injury, myocardial injury and even death," said Kamal Maheshwari, M.D., MPH, anesthesiologist from Cleveland Clinic Foundation. "The noninvasive Acumen IQ cuff provides the opportunity to reduce hypotension in a broader range of patients, including those who do not require an invasive arterial line. The cuff, along with the predictive capabilities of Acumen HPI software to proactively manage hypotension, will have a meaningful impact on patients."

In addition to unlocking predictive capabilities, Acumen IQ cuff provides access to automatically calculated, beat-to-beat hemodynamic parameters including mean arterial pressure and cardiac output. It will be available on the HemoSphere advanced monitoring system in the coming weeks.

"This latest predictive technology demonstrates our commitment to patient care and providing clinicians with 'smart' monitoring tools that allow for better prediction and management," said Katie Szyman, Edwards' corporate vice president, critical care. "We are extremely optimistic about launching Acumen IQ cuff and providing a tool to help clinicians make informed decisions for their patients, with the goals of reducing complications and helping patients with a quicker return to their families and their daily lives."

About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.

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. Maheshwari and Ms. Szyman and expectations regarding the potential benefits of HemoSphere, Acumen Hypotenstion Prediction Index, 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, 2020 and its subsequent quarterly reports on Form 10-Q. 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, Acumen IQ, HemoSphere, and HPI, are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

SOURCE Edwards Lifesciences Corporation


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Media Contact: Sarah Huoh, 949-250-5070, or Investor Contact: Mark Wilterding, 949-250-6826