Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment

Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation too often suffer a variety of side effects.

These can include ventilator associated lung injury, pneumonia, and diaphragm dysfunction. Moreover, related sedation and lack of movement can aggravate an already difficult situation.

To help address some of the challenges of utilizing mechanical ventilation, the FDA has just cleared the Novalung System, a product of Fresenius Medical Care, that lets clinicians choose to use extracorporeal gas exchange over mechanical ventilation when managing patients for extended periods of time.

The Novalung System is an all-in-one device that performs everything from CO2 exchange to oxygenation of the blood, and it has been cleared to do so for over six hours, an industry first.

Not having to push on the lungs, as with conventional ventilation, extracorporeal membrane oxygenation (ECMO) allows the lungs to heal while avoiding issues noted above. Moreover, intubation is not necessary, and patients can experience spontaneous breathing and even be taken for walks around the clinical ward.

The Novalung System is controlled via a touchscreen monitor that displays all the relevant patient data, as well as the status of the pump and its other hardware components. It runs from a standard power outlet, but includes internal batteries that will maintain operation even if the clinic’s power goes out.

The system is indicated for patients with acute respiratory failure or acute cardiopulmonary failure for whom other options have failed and they continue to deteriorate.