The US FDA has cleared the Novalung extracorporeal membrane oxygenation (ECMO) system for the treatment of acute respiratory or cardiopulmonary failure, according to Fresenius Medical Care North America (FMCNA). Novalung is the first ECMO system to be cleared for more than six hours of use as extracorporeal life support, the company said.

The Novalung System is indicated for long-term (>6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure.

The therapy is designed for use in clinical care settings such as intensive care units, operating rooms, cardiac catheterization labs, and emergency departments, for patients where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

  • Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients; or
  • ECMO-assisted cardiopulmonary resuscitation in adults.

“A long-term, effective ECMO solution gives critically-ill patients the time and support needed to heal,” said Dr Robert Bartlett, professor emeritus, University of Michigan School of Medicine. “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 use of Novalung as an ECMO device for critical care has several benefits, including minimizing the need for invasive ventilation, the ability to provide support after multi-organ injuries, and better survival outcomes for patients in cardiac arrest, according to FMCNA. This integrated heart and lung therapy platform provides the lifesaving support needed for patients in critical conditions, the company said.

“Novalung is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before,” said Mark Costanzo, president of FMCNA’s Renal Therapies Group. “We’ve applied our leadership and technical expertise in renal medical devices to elevate standards for acute respiratory and cardiopulmonary failure treatments and technologies. We’re proud to broaden our care offerings to provide new therapies for patients with acute cardiopulmonary conditions.”

FMCNA expects Novalung to be available within the U.S. mid-year 2020. More information is available at the Novalung website.