FDA clears Novalung’s heart and lung support system

25 February 2020 (Last Updated February 26th, 2020 09:42)

The US Food and Drug Administration (FDA) has cleared Novalung, a heart and lung support system developed by Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure.

FDA clears Novalung’s heart and lung support system
Novalung is a heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure. Credits: PRNewsfoto/Fresenius Medical Care Holdings.

The US Food and Drug Administration (FDA) has cleared Novalung, a heart and lung support system developed by Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure.

Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support. The system pumps and oxygenates a patient’s blood, reducing the stress on damaged hearts and lungs.

It offers an alternative to invasive mechanical ventilation, which can cause additional lung injury as a result of the air pressure required.

During acute respiratory or cardiopulmonary failure, the level of oxygen in the patient’s body often becomes dangerously low due to the inability to breathe in oxygen or expel carbon dioxide, which can also cause a wide range of other conditions.

ECMO has been linked to improved survival rates and no increase in hospitalisation costs when used on these patients.

University of Michigan School of Medicine professor Robert Bartlett said: “A long-term, effective ECMO solution gives critically-ill patients the time and support needed to heal. 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 pressure sensor technology embedded in the Novalung system allows continuous monitoring and precise control of the blood flow in patients.

Furthermore, it provides a portable therapy solution that can adapt to various clinical care settings, such as operating rooms, intensive care units and emergency departments.

FMCNA’s technologies and pharmaceuticals division Renal Therapies Group president Mark Costanzo said: “Novalung is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before.

“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.”

Novalung should be available in the US by mid-2020.