Novalung ECMO system will pump and oxygenate a patient's blood to minimise the pressure on damaged heart and lungs
Fresenius has secured FDA approval for Novalung heart and lung support system (Credit: PRNewsfoto/Fresenius Medical Care Holdings)
Healthcare company Fresenius Medical Care North America (FMCNA) has secured approval from the US Food and Drug Administration (FDA) for its Novalung heart and lung support system to treat acute respiratory or cardiopulmonary failure.
Novalung is claimed to be the first extracorporeal membrane oxygenation (ECMO) system received approval for more than six hours of use as extracorporeal life support.
The Novalung ECMO system has been developed to pump and oxygenate a patient’s blood, enabling to minimise the pressure on damaged heart and lungs.
The system delivers long-term respiratory/cardiopulmonary support, which offers assisted extracorporeal circulation and physiologic gas exchange of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure.
The Novalung system serves as an alternative to invasive mechanical ventilation, which may result in additional lung injury due to the air pressure.
Novalung system also delivers a portable therapy solution to improve clinical outcomes
The system also provides a portable therapy solution that can enhance clinical outcomes. It can be used in different clinical care settings such as intensive care units, operating rooms, cardiac catheterization labs, and emergency departments.
Novalung can also be used as an ECMO device in critical care applications, helping to avoid invasive ventilation and provides support after multi-organ injuries. It also facilitates better survival outcomes for patients in cardiac arrest.
In addition, the integrated heart and lung therapy platform offer the required support for patients in critical conditions.
FMCNA technologies and pharmaceuticals division’s renal therapies group president Mark Costanzo said: “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.”
In October 2019, FMCNA secured breakthrough device designation from the US Food and Drug Administration (FDA) for its new haemodialysis system.