Edwards’ HemoSphere Platform Receives Expanded Use Indication From Health Canada in Treatment of COVID-19 Patients

IRVINE, Calif., April 27, 2020 (GLOBE NEWSWIRE) -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that Health Canada approved an expanded indication for use of the HemoSphere advanced monitoring platform in the treatment of COVID-19 patients. This approval was granted following an interim order issued by Health Canada to address the pressing need for medical supplies used in the response to the COVID-19 pandemic. 

Hemodynamic monitoring refers to the measurement and tracking of different vital signs that help manage blood flow and oxygenation in critically ill patients, like those who are being treated for COVID-19. These patients can be at increased risk of developing conditions such as sepsis and acute respiratory distress syndrome (ARDS) when their vital signs go out of range. By monitoring a patient’s hemodynamics, clinicians can detect changes or problems in a patient's health, which enables them to make more informed and immediate treatment decisions.

“Studies show that patients with COVID-19, especially those who develop respiratory issues, have a much higher risk of serious complications like organ failure, and even death,” said Katie Szyman, Edwards’ corporate vice president, critical care. “Edwards is proud to support Health Canada and all of the healthcare workers on the front lines who are working tirelessly to manage the COVID-19 crisis and provide care for critically ill patients.”

The HemoSphere platform also utilizes several tools to monitor fluid levels in patients. For critically ill patients with COVID-19, monitoring the amount of fluid that these patients are receiving is important, as giving too much or too little fluid could worsen their breathing. Considering the rapidly changing and complex nature of critically ill patients with COVID-19, the availability of continuous hemodynamic information can help clinicians determine the right intervention to help keep patients stabilized.  

About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease and critical care 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 Ms. Szyman and statements regarding expected product benefits, patient outcomes, future plans related to the product lines, objectives and expectations and other statements that are not historical facts. 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 unexpected outcomes after more expanded clinical experience, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, or unexpected delays or changes in patient access, litigation or clinician acceptance. These 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, 2018.

Edwards, Edwards Lifesciences, the stylized E logo, and HemoSphere are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

Media Contact: Rich Ferreira, 949-250-5782

Investor Contact: Mark Wilterding, 949-250-6826