Therapy Areas: Cardiovascular
FMCNA passes FDA clearance for Novalung to treat acute respiratory and cardiopulmonary failure
25 February 2020 -

Healthcare company Fresenius Medical Care North America (FMCNA) revealed on Monday that its heart and lung support system Novalung, for treating acute respiratory or cardiopulmonary failure, has received approval from the US Food and Drug Administration (FDA) .

According to the company, Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support. Recent research has shown a significant increase in the use of ECMO with evidence of improved survival rates and no increase in hospitalization costs. Patients in acute respiratory or cardiopulmonary failure often struggle to get oxygen into their bloodstream or expel carbon dioxide out of their bodies, resulting in dangerously low levels of oxygen.

The company added that the Novalung ECMO system pumps and oxygenates a patient's blood, reducing the stress on damaged heart and lungs.

Additionally, the company's Novalung offers an alternative to the need for invasive mechanical ventilation, which can cause additional lung injury. It offers a portable therapy solution designed to improve clinical outcomes and accommodate various clinical care settings including intensive care units, operating rooms, cardiac catheterization labs and emergency departments.

In conjunction, the company expects Novalung to be available within the US mid-year 2020.

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