US-based Vapotherm has received the CE Mark approval for its Vapotherm Oxygen Assist Module (OAM), which is used with a Precision Flow system.

The medical device manufacturer said that its advanced OAM will enable clinicians to keep their patients in the desired oxygen saturation range effectively, compared to manual control alone.

Vapotherm is engaged in developing advanced, non-invasive technologies to support patients with chronic breathing disorders.

Vapotherm president and CEO Joe Army said: “Oxygen is a deadly, dangerous, life-giving drug with a narrow therapeutic index and it can be especially dangerous for babies.

“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.”

According to the company, more than 180,000 premature babies around the world are developing retinopathy of prematurity (ROP) due to exposure to oxygen, which leads to the risk for visual impairment, and even blindness.

Maintaining prescribed oxygen saturation range for babies would reduce the health risks associated with over dosage, or under dosage of oxygen, including visual impairment in premature infants.

Patients can talk, eat, drink and take oral medication while using the Vapotherm OAM

Vapotherm OAM has been designed to integrate with the company’s precision flow system which offers Hi-VNI Technology, a mask-free alternative to nCPAP non-invasive positive pressure ventilation (NiPPV) in neonates and adults.

Hi-VNI Technology provides ventilation for spontaneously breathing patients and relieves respiratory distress including hypercapnia, hypoxemia, and dyspnea.

The company said that the effectiveness of Vapotherm OAM was evaluated in a 2018 clinical study, and its advanced OAM device will facilitate fast and safe treatment of undistinguished respiratory distress.

In addition, the mask-free interface offered by the Hi-VNI Technology will deliver optimally conditioned breathing gases, which offers comfort for patients and reduced the risks and care complexities related to mask therapies.