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Home » Fresenius to launch a mechanical ventilators alternative in U.S.

Fresenius to launch a mechanical ventilators alternative in U.S.

February 24, 2020 By Chris Newmarker

Fresenius Novalung
[Novalung image courtesy of Fresenius]
Fresenius (NYSE:FMS) announced today that it has achieved a 510(k) clearance for its Novalung system — which reduces or eliminates the need for mechanical ventilation by pumping a person’s blood through an oxygenator for gas exchange.

Fresenius boasted that the Novalung is the first extracorporeal membrane oxygenation (ECMO) system cleared to provide more than six hours of outside-the-body life support.

The company is planning a U.S. launch in mid-2020.

“Novalung is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before,” said Mark Costanzo, president of Fresenius Medical Care North America’s Renal Therapies Group.

“We’ve applied our leadership and technical expertise in renal medical devices to elevate standards for acute respiratory and cardiopulmonary failure treatments and technologies,” Costanzo said.

Acquired through Fresenius’s purchase of Xenios in 2016, the Novalung system requires only low blood flow rates and relatively small cannulas, comparable to a dialysis system. It “breathes” on behalf of a person — outside the person’s body.

Fresenius boasts that Novalung products can replace or reduce invasive mechanical ventilation, reducing side effects and giving a person’s lungs the chance to heal. The system can perform any level of CO2 removal and oxygenation in acute respiratory failure — which means it’s possible to tailor the system to each person’s individual needs.

“A long-term, effective ECMO solution gives critically-ill patients the time and support needed to heal,” said Dr. Robert Bartlett, professor emeritus at the University of Michigan School of Medicine. “The system’s pressure sensor technology ensures continuous monitoring and accurate flow control of each patient’s blood, allowing the care team the flexibility needed to treat the underlying health issues.”

 

Filed Under: 510(k), Business/Financial News, Featured, Regulatory/Compliance Tagged With: Fresenius

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