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Novalung System receives US FDA Clearance

The US FDA (Food and Drug Administration) has granted 510(k) approval to Xenios - a Fresenius Medical Care company

ID: 1556371
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(PresseBox) - The US FDA (Food and Drug Administration) has granted 510(k) approval to Fresenius Medical Care North America and Xenios, a Fresenius Medical Care company, for long-term use of its Novalung system for patients with acute lung failure or acute cardiopulmonary failure. The FDA announced this on Friday evening.

With Class II approval, the Novalung system is the first complete system approved for ECMO therapy (ECMO = extracorporeal membrane oxygenation) and long-term use for a duration of more than six hours. This enables physicians to provide their patients suffering from acute lung failure or acute cardiopulmonary failure with ECMO therapy over a longer period of time using a single device. In addition, the Novalung system can be used to apply extracorporeal CO2 removal (ECCO2R) for severe lung diseases.

The whole system consists of the Novalung console and the XLung kit. The market launch in the US is planned for the middle of this year.

"The approval is an acknowledgement of the high quality standard of our products to which we are committed as part of Fresenius Medical Care," explains Andreas Terpin, CEO of Xenios, and adds: "A particular success for us is the wide range of the approval from ECMO to ECCO2R.?

The clearance of the Novalung system was strengthened by clinical data from a retrospective analysis of approximately 150 patients who had received ECMO treatment. According to the FDA, the results showed that the Novalung system''s clinical efficacy and safety supports a long-term ECMO treatment and that the system is suitable for the entire spectrum of venovenous and venoarterial support.

Xenios AG - a company of the Fresenius Medical Care Group - is a pioneer in extracorporeal heart and lung support. The Novalung and Medos products offer a wide range of heart and lung support products via a single platform, the Xenios console.

Xenios'' mission is to improve patient well-being and care. The Novalung therapy aims at a paradigm shift in lung support: enabling the treatment of patients who are awake, self-determined and mobile.



Xenios AG has been part of Fresenius Medical Care, the world''s leading provider of products and services for people with kidney disease since the end of 2016. Xenios complements the group''s portfolio in the area of holistic multi-organ support of Fresenius Medical Care.

www.xenios-ag.com



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Xenios AG - a company of the Fresenius Medical Care Group - is a pioneer in extracorporeal heart and lung support. The Novalung and Medos products offer a wide range of heart and lung support products via a single platform, the Xenios console.Xenios'' mission is to improve patient well-being and care. The Novalung therapy aims at a paradigm shift in lung support: enabling the treatment of patients who are awake, self-determined and mobile.Xenios AG has been part of Fresenius Medical Care, the world''s leading provider of products and services for people with kidney disease since the end of 2016. Xenios complements the group''s portfolio in the area of holistic multi-organ support of Fresenius Medical Care.www.xenios-ag.com

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published by: PresseBox
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Date: 02/26/2020 - 14:56
Language: English
News-ID 1556371
Character count: 2624
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Firma: Xenios AG
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