News • ECMO treatment

FDA clearance for extracorporeal life support system

The U.S. Food and Drug Administration (FDA) 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.

product photo of novalung device
The Novalung system
Source: Fresenius Medical Care

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 U.S. 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.


Source: Xenios

27.02.2020

Related articles

Photo

News • Earlier detection and treatment

Exploring the potential of X-ray imaging for IPF

Carestream Health is funding and participating in an innovative pilot with OSIC that could lead to radiographs providing an early window into manifestations of IPF that are currently undetected.

Photo

Article • ICU response to the Covid-19 surge

Tele-delivery of respiratory therapy services: a resounding success

In their pursuit of solutions for pandemic challenges, a US hospital system applied telemedicine principles to respiratory therapy – with impressive results.

Photo

News • Resistance building prevention

New test to reduce antibiotics in primary care

Antibiotic prescribing in primary care could be monitored using health insurance data. And reduced with a simple test.

Related products

Subscribe to Newsletter