Novalung System Granted 510(k) Clearance for Whole ECMO System

The US Food and Drug Administration (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, according to a letter from the FDA.

With class 2 approval, the Novalung System becomes the first whole ECMO 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.

The Novalung System was backed by clinical data from a retrospective analysis of 148 patients receiving ECMO treatment. Results of the analysis demonstrated the performance and safety of the Novalung System support a long-term ECMO indication and that the system provided both venovenous and venoarterial support, the FDA said in a statement.

The Novalung System consistent of a Novalung console, which is composed of a control panel, power supply, sensor box, and pump drive, and an XLung kit. The console powers and monitors the operation of the blood pump while the control panel and a touchscreen display to display all the data.

The XLung Kit contains a disposable tubing set and accessories. The set is connected to the XLung oxygenator and blood pump head. The entire system is attached to a power supply, but also comes equipped with 2 battery packs to power the console in the event of a power failure.

The FDA’s letter specifically notes the Novalung System is indicated for use in a hospital environment to provide extracorporeal cardiac and/or pulmonary support. The Novalung System is for patients for which other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.