The US regulator also granted a new product category and product code (QAV) for the Precision Flow Hi-VNI system, which is Vapotherm’s latest version of the Precision Flow product.

The Vapotherm Precision Flow Hi-VNI system is is claimed to be the only product currently in the QAV category.

Vapotherm medical education vice president Michael McQueen said: “We are delighted with the grant of this new product code by the FDA. We believe it clarifies the appropriate clinical use of Hi-VNI Technology and informs clinicians that it is safe to use as a tool to treat undifferentiated respiratory distress.

“It emphasizes that Hi-VNI Technology has a similar clinical application of ventilatory support to the standard of care of NiPPV, but without the tight-fitting mask.”

Hi-VNI Technology works by flushing out the carbon dioxide heavy and oxygen depleted exhaled air from the respiratory dead space in the upper airway between breaths. This is replaced with optimally humidified oxygen rich breathing gas delivered through a nasal cannula.

The process results in a non-invasive ventilatory support and reduces the work of breathing, allowing the patient to eat, drink and speak, as there is no mask involved. It can also help in preventing mask-related risks of claustrophobia, aspiration and pressure ulcers.

In order to gain the expanded claims and the first in category grant, the company claims to have submitted clinical data that Hi-VNI Technology can safely be used in treating undifferentiated respiratory distress in patients, including newborns to adults.

The conventional standard of care for non-invasive management of such patients has been NiPPV. This is a pressure-based form of non-invasive ventilation.

Vapotherm cited its clinical evidence and stated that the Hi-VNI Technology, which is found in all of Vapotherm’s Precision Flow products, is non-inferior to NiPPV in preventing mechanical ventilation.

It also stated that mechanical ventilation can substantially increase risk of infections in patients, increase ventilator dependence, and mortality, as well as increases costs to the hospital, and is typically used only when other approaches have been exhausted.