Getinge’s new Flow-e and Flow-c anesthesia machines receive 510(k) clearance

Sept. 1, 2020

Getinge released that the U.S. Food and Drug Administration (FDA) has cleared its Flow-e and Flow-c anesthesia systems, which share the same Flow Family core technology and offer personalized anesthesia delivery for even the most challenging patients, from neonates and pediatric to the morbidly obese.

Developed together with clinicians, these machines are designed to facilitate personalization with patient safety in mind.

“Every detail of this machine has been designed in collaboration with clinicians to ensure optimal care with high efficiency. Flow-e has a smart workspace that makes work easier in the busy OR environment,” explains Lena Evander, Director Product Management Anesthesia at Getinge. “The tools are right where you would want them to be, which makes it possible to work in an ergonomic and comfortable position.”

“FDA 510(k) clearance of Getinge’s Flow-e and Flow-c allows us to complete the portfolio of Flow anesthesia machines and offers innovative solutions with personalized anesthesia for high-acuity patients in the large and expansive US marketplace,” said Eric Honroth, President of North America.

The Flow Family core technology includes gas modules that are common with Servo ICU ventilators, allowing lung-protective ventilation and the optional Lung Recruitment Maneuvers tool, which is available on Flow-e and Flow-i models. Lung Recruitment Maneuvers have become the tool of choice to counter atelectasis, improve oxygenation, and help prevent postoperative complications.

The Flow-e and Flow-c will be launched with upgraded software, version 4.7, which includes the MAC Brain indicator, a unique tool that visualizes the difference in agent concentration between the lungs and target organ, the brain. The reliability of the data places anesthesiologists in control, which allows planning and delivery of more efficient agent dosing. The other members of the Flow family will have access to the software upgrade in the coming weeks.

All models in Getinge’s Flow Family include O2Guard, a system for active hypoxia prevention. O2Guard automatically overrules the settings and increases the flow of oxygen if the inspired oxygen level drops below 21percent, minimizing the risk of hypoxia in challenging patient types.

Getinge has the release.

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