February 25, 2020
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Long-term ECMO system receives FDA clearance

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The FDA recently cleared the Novalung extracorporeal membrane oxygenation system — the first to be cleared for more than 6 hours of use as extracorporeal life support — for treatment of acute respiratory or cardiopulmonary failure, according to a press release from Fresenius Medical Care North America.

The Novalung ECMO system (Fresenius Medical Care) is indicated for long-term respiratory or cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other treatment options have failed, and continued clinical deterioration is expected or the risk for death is imminent.

The system may be an attractive option, as it offers an alternative to the need for invasive mechanical ventilation and represents a portable therapy solution that can accommodate various clinical care settings, such as ICUs, operating rooms, cardiac cath labs and EDs, according to the release.

The FDA recently cleared the Novalung extracorporeal membrane oxygenation system — the first to be cleared for more than 6 hours of use as extracorporeal life support — for treatment of acute respiratory or cardiopulmonary failure, according to a press release from Fresenius Medical Care North America.
Credit: Fresenius Medical Care Holdings

“A long-term, effective ECMO solution gives critically ill patients the time and support needed to heal,” Robert Bartlett, MD, professor emeritus in the section of general surgery, division of acute care surgery at the University of Michigan School of Medicine, said in the release. “The system’s pressure sensor technology ensures continuous monitoring and accurate flow control of each patient’s blood, allowing the care team the flexibility needed to treat the underlying health issues.”

Disclosure: Healio Pulmonology could not confirm relevant financial disclosures at the time of publication.