Fresenius SE & Co. KGaA

02/25/2020 | Press release | Distributed by Public on 02/25/2020 03:15

FDA clears Fresenius Medical Care’s Novalung for treatment of acute respiratory and cardiopulmonary failure

Fresenius Medical Care, the world's leading provider of dialysis products and services, today announced that the U.S. Food and Drug Administration (FDA) has cleared Novalung®, a heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure. Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support. The company expects Novalung to be available within the U.S. mid-year 2020.

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. This acute low oxygen state can result from a wide range of conditions.

The Novalung ECMO system pumps and oxygenates a patient's blood, reducing the stress on damaged heart and lungs. Novalung offers a portable therapy solution designed to improve clinical outcomes and accommodate various clinical care settings such as intensive care units, operating rooms, cardiac catheterization labs, and emergency departments.

The use of Novalung as an ECMO device for critical care has several benefits, including minimizing the need for invasive ventilation, the ability to provide support after multi-organ injuries, and better survival outcomes for patients in cardiac arrest.

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.