FDA OKs Novalung ECMO for Respiratory and Cardiopulmonary Failure

Megan Brooks

Disclosures

February 24, 2020

The US Food and Drug Administration (FDA) has cleared the Novalung heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure.

Novalung, from Fresenius Medical Care North America (FMCNA), is the first extracorporeal membrane oxygenation (ECMO) system approved for long-term (>6 hours) extracorporeal life support.

Novalung is indicated for use in cases in which other available treatment options have failed and continued clinical deterioration is expected or the risk for death is imminent. These may include cases of failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients and cases involving ECMO-assisted cardiopulmonary resuscitation in adults.

The system is portable and can be used in various clinical care settings, such as intensive care units, surgical suites, cardiac catheterization laboratories, and emergency departments, the company said in a news release.

"Novalung is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before," Mark Costanzo, president of the renal therapies group at FMCNA, said in the release.

"A long-term, effective ECMO solution gives critically-ill patients the time and support needed to heal," Robert Bartlett, MD, professor emeritus of surgery, University of Michigan School of Medicine, Ann Arbor, 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."

The company expects Novalung to be available in the United States later this year.

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