FDA 510K approval for Novalung to treat long term acute respiratory/cardiopulmonary failure. Xenios AG/ Fresenius

The FDA has granted 510(k) approval to the Novalung system for long-term respiratory/cardiopulmonary support in patients with acute respiratory failure or acute cardiopulmonary failure to Fresenius Medical Care. With class 2 approval, the Novalung System becomes the first whole ECMO ( Extracorporeal membrane oxygenation) system labeled for ECMO therapy and for a duration greater than 6 hours—allowing physicians to provide ECMO therapy to patients using a single device over an extended period of time. Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation too often suffer a variety of side effects. Such as ventilator associated lung injury, pneumonia, and diaphragm dysfunction. In addition, 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 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. Comment: Novalung therapy allows to mitigate, prevent or replace mechanical ventilation by extracorporeal gas exchange. It enables caregivers to give the lung time to heal and change the therapy environment in the ICU – from CO2 removal to full oxygenation.