Getinge’s servo-air mechanical ventilator receives 510(k) clearance

Getinge has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the company’s Servo-air mechanical ventilator, which is part of the Servo family that supports intensive care ventilation.
“We are happy to be able to help clinicians in their endeavor to save lives by adding an additional ventilator to our product offering in the U.S. market,” commented Elin Frostehav, vice president critical care at Getinge. “This is also an important step for our ventilation business in other parts of the world where 510(k) approval is a prerequisite for governmental tenders.”

Servo-air is a critical care ventilator intended for pediatric and adult patients. It includes both Invasive and Non-Invasive (NIV) ventilation modes. Servo-air also features options for High Flow therapy and Servo Compass, which allows lung protective ventilation and makes it easier to follow the ARDSnet protocol.

“The turbine driven Servo-air is independent from wall gas. This, in combination with its high battery capacity, makes it suitable for use in intensive care units as well as for intermediate care and intra-hospital transportation,” said Malin Graufelds, global product manager Servo-air.

Mechanical ventilation is a key component in the ongoing fight against the new coronavirus COVID-19. Although the majority of people with COVID-19 experience an uncomplicated or mild illness, some will develop critical illness and require mechanical ventilation.

“For patients with severe impairment of oxygenation, such as ARDS, it is important to use a ventilation strategy with the potential to improve patient outcomes and optimize the benefit-to-cost ratio for the lungs, heart and the respiratory muscles,” Frostehav concluded. –MPO

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