Vapotherm Receives CE Mark for Oxygen Assist Module in European Union


Vapotherm, Inc. announced that it has received the CE Mark for its Vapotherm Oxygen Assist Module (OAM). When used with a Precision Flow® system, the Vapotherm OAM helps clinicians keep their patients within the target oxygen saturation range more effectively than with manual control alone. Keeping babies in the prescribed oxygen saturation range may reduce the health risks associated with dosing too much or too little oxygen – such as visual or developmental impairment in premature infants.

“Oxygen is a deadly, dangerous, life-giving drug with a narrow therapeutic index and it can be especially dangerous for babies,” said Joe Army, President and CEO of Vapotherm. “Too much or too little oxygen can lead to serious consequences. We are very proud to be able to offer clinicians a new tool in helping to maintain appropriate clinical oxygen levels in these babies.”

Clinicians focus significant effort on maintaining blood oxygen saturation within prescribed ranges in order to address these potential consequences, which are significant in scope. For example, more than 180,000 premature babies worldwide develop some degree of retinopathy of prematurity (ROP)—putting them at risk for visual impairment, including blindness, due to too much oxygen exposure. Additionally, the prevalence of ROP is increasing as infant mortality rate decreases.

The effectiveness of the Vapotherm OAM algorithm was validated in a 2018 study published by Reynolds and colleagues in the Archives of Disease in Childhood: Fetal and Neonatal Edition. The data show that trained staff using manual controls alone were able to maintain premature infants’ oxygen saturation in the physician-prescribed target range 49% of the time. When using the Vapotherm device, the staff were able to maintain the target oxygen saturation range 80% of the time, while at the same time requiring significantly fewer adjustments to the equipment. The study refers to the algorithm in the OAM by its prototype name of IntellO2.

Vapotherm OAM integrates with Vapotherm’s Precision Flow system​. The Precision Flow system provides Hi-VNI® Technology, which has been clinically proven to be a mask-free and seal-free alternative to nCPAP as well as noninvasive positive pressure ventilation (NiPPV) in neonates and adults.

Source: Vapotherm

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