As the demand for ventilators increased due to the ongoing COVID-19 pandemic, Getinge, a global supplier of mechanical ventilators, was faced with the challenge of ramping its production up 160 percent during 2020.
On Wednesday, the Sweden-based company with North American headquarters in Wayne, received 510 (k) clearance from the U.S. Food & Drug Administration for its Servo-air mechanical ventilator for use with adult and pediatric patients dependent on intensive care ventilation.
510(K) is a premarket submission made to the FDA to demonstrate that the device to be marketed is safe and effective.
“FDA 510(k) clearance for Servo-air will broaden our U.S. offering with a turbine-driven ventilator,” said Getinge North America President Eric Honroth. “The Getinge Servo platform holds a leadership position in the U.S. marketplace, further expanding Getinge’s global ventilation business.”
Servo-air is a high performing ventilator intended for adult and pediatric patients with both invasive and non-invasive (NIV) ventilation modes, including high flow therapy and Servo Compass options. Various modes allow clinicians to adapt and personalize ventilation to the patient and situation.
Honroth added: “Servo-air has the same proven easy to use interface with the same context based guidance as the Servo-u ventilator.”
According to a company press release, Servo-air is turbine-driven and independent from wall gas that allows for powerful, uninterrupted, quiet ventilation benefitting intensive care patients. It is suited for intra-hospital transport, intermediary, or intensive care. Dual, hot swappable batteries allow set up anywhere in the intensive care unit with powerful performance and optimal endurance.
Mechanical ventilation is a key component in the ongoing fight against COVID-19. “In partnership with intensive care clinicians, Getinge’s Servo-air can help save lives in the U.S. market,” Honroth said.
Servo-air is expected to be available in the U.S. in late 2020.