FDA Approves Novalung to Provide Long-Term Lung Failure Treatment

Critically ill patients suffering from acute respiratory or cardiopulmonary failure require long-term mechanical ventilation. Thus, they often suffer from a variety of side effects. These side effects can include ventilator associated lung injury, diaphragm dysfunction, and pneumonia. Sometimes, related sedation and lack of movement can also aggravate an already difficult situation.

To prevent these side effects, the Food and Drug Administration (FDA) has cleared the Novalung System. This is a new product developed by Fresenius Medical Care. Novalung System allows clinicians to choose to use extracorporeal gas exchange over mechanical ventilation when managing patients for long periods of time.

The Novalung System is an all-in-one device that can perform different functions including CO2 exchange and oxygenation of the blood. It has been cleared by FDA to perform these tasks for over six hours, an industry first.

Conventional ventilation pushes on the lungs that can cause lungs to strain. Extracorporeal membrane oxygenation (ECMO) allows the lungs to heal while avoiding other health issues. As intubation is not necessary, patients can experience spontaneous breathing and even be taken for walks around the clinical ward.

The Novalung System is controlled via a touchscreen monitor. This monitor displays all the relevant patient data, along with the status of the pump and its other hardware components. Although running from a standard power outlet, it includes internal batteries that will maintain operation even if the clinic’s power goes out.

The system indicates for patients with acute cardiopulmonary failure or acute respiratory failure for whom other options have failed and their health continues to deteriorate.

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