Research & Development
Vapotherm announces US FDA approval for new category Vapotherm Hi-VNI system, with world-wide launch by January 2019
10 October 2018 -

Respiratory technology company Vapotherm Inc reported on Tuesday the receipt of the US Food and Drug Administration (FDA) new product category and product code (QAV) for the latest version of the Precision Flow product, the Precision Flow Hi-VNI system, to treat undifferentiated respiratory distress.

This version of the Precision Flow is expected to be widely available around the world by January 2019.

The US FDA has awarded an expanded indication for the the Precision Flow Hi-VNI system, which states that it may be used to augment breathing of spontaneously breathing patients suffering from respiratory distress in a hospital setting. The system includes certain updates to the internal electronics to comply with the latest standards for medical device equipment. It also includes updates to software and instructions for use appropriate to this patient population.

Vapotherm added that the Vapotherm Precision Flow Hi-VNI system is currently the only product in the QAV category and the Precision Flow Hi-VNI system is a viable alternative to Non-invasive Positive Pressure Ventilation (NiPPV) for most patients.

According to the company, the Hi-VNI Technology flushes the carbon dioxide heavy and oxygen depleted exhaled air from the respiratory dead space in the upper airway between breaths, replaces it with optimally humidified oxygen rich breathing gas, providing non-invasive ventilatory support and reducing the work of breathing.

The company stated that submitted clinical data of the Hi-VNI Technology, which can safely and effectively be used in the treatment of undifferentiated respiratory distress in patients, ranging from newborns to adults. The clinical evidence demonstrated similar effectiveness to NiPPV in preventing mechanical ventilation in patients regardless of the cause of the respiratory distress and whether the patient's primary problem was getting enough oxygen or getting rid of enough carbon dioxide.



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