Edwards Lifesciences Announces FDA Clearance of HemoSphere CX Critical Care Monitoring Platform

IRVINE, Calif., September 3, 2019 -- Edwards Lifesciences Corporation announced that the U.S. Food and Drug Administration (FDA) has granted clearance for a smart cable enabling compatibility between the company’s ForeSight tissue oximetry (brain oxygenation) sensors and HemoSphere advanced monitoring platform.


The ForeSight sensor is Edwards’ latest non-invasive offering and is part of a unique set of smart recovery tools available on a single monitor. Edwards obtained the ForeSight technology in April 2019 through an acquisition with CAS Medical Systems, Inc., and the integration of the ForeSight sensor with the HemoSphere monitor is a result of a multi-year collaboration between both companies that demonstrates a shared commitment to helping patients.


The HemoSphere CX critical monitoring platform. The platform now includes the compatibility between its non-invasive ForeSight tissue oximetry (brain oxygenation) sensors and its HemoSphere advanced patient monitoring system, allowing anesthesiologists and surgical teams (including cardiac) to have more a complete view of a patient’s status during surgery so they can address potential complications quicker and earlier, and optimize care for the patient throughout a procedure.


“During surgical procedures where patients cannot convey symptoms of reduced brain perfusion due to general anesthesia or sedation, decreased oxygen levels in the brain can have lasting effects and could result in complications as well as increased time spent in the hospital,” said Charles Hogue, MD, Professor of Anesthesiology and Chairman of the Department of Anesthesiology at Northwestern University Feinberg School of Medicine in Chicago, IL. “Combining advanced hemodynamic monitoring with tissue oximetry provides a more complete view of patients’ oxygen levels and oxygen use, allowing clinicians to optimize care for their patients throughout a procedure.”


Decreases in oxygen levels in the brain are associated with complications such as cognitive dysfunction and delirium, and can result in extended time on ventilation machines or in intensive care units. Cerebral oximetry is the only non-invasive indicator of brain oxygenation available to anesthesiologists and surgical teams. As part of the HemoSphere platform, ForeSight sensors can be utilized in combination with other advanced monitoring and decision-support tools to provide a comprehensive view of a patient’s hemodynamic status.


“Understanding the relationship between the heart and the brain can provide valuable patient insights to support decision making during a surgical procedure,” said Katie Szyman, Edwards’ corporate vice president, critical care. “With the addition of the ForeSight sensors to Edwards’ most modern platform, HemoSphere, we can offer clinicians a broad range of smart hemodynamic management solutions to help improve patient care.”


Dr. Hogue 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 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.