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

FEBRUARY 21, 2020
Patrick Campbell
FDA approvalThe 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.

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