Getinge receives three ventilator-related FDA clearances

Getinge has received clearance from the US FDA for several new software options for the Servo-u and Servo-n ventilators. In addition to the latest software upgrades, Getinge also received clearance for the new Servo-u MR ventilator for the MRI room. 

Eric Honroth, president, Getinge North America, said: “The COVID-19 pandemic and the heightened awareness of respiratory health has driven the need for personalised ventilation solutions for critically ill patients. Now more than ever, options for personalised lung protection and personalised weaning solutions are at the forefront of respiratory patient health. Getinge strives to support clinicians and patients by optimising lung protection and delivering solutions for personalised ventilation.”

With this software upgrade for the Servo-u and Servo-n combined, several new functionalities and options across all patient categories – adult, paediatric and neonatal. Getinge broadens its portfolio of lung-protective tools, including Automatic Stepwise Recruitment manoeuvre (Auto SRM), a standardised and automated workflow that guides lung recruitment and helps clinicians identify a personalised PEEP that provides the lowest driving pressure, which is a variable strongly associated with patient survival in ARDS1. Stress index and Transpulmonary pressure monitoring, including key parameters for assessment of lung stress during controlled and spontaneous ventilation, complements the lung protective toolkit, which was designed to optimally divide the cognitive workload between the clinician and the ventilator.

The clearance includes Heliox therapy. Heliox is a mixture of helium and oxygen that facilitates laminar flow and minimises airway pressure due to its low density. This helps reduce the work of breathing (WoB) of patients suffering from obstructive lung diseases. 

Getinge also received clearance to introduce the Servo-u MR to the US market, a complement to the Servo Family, expanding Getinge’s platform of ventilators into the MRI room. Designed to guide the ventilator into a safe position, the Servo-u MR includes a magnetic field indicator with visual and audible alerts and an auto-lock handle that locks all four wheels as soon as the clinician releases the ventilator.  

Honroth added: “We are seeing a transformation in the way healthcare providers view respiratory health. With this clearance, we are excited to be part of driving this transformation, working hand in hand with experts and clinicians.”

The new options and the Servo-u MR ventilator are expected to be available in the U.S. in July 2021.