3D-printed sleep apnoea device cleared by FDA

Australian medical device company Oventus Medical has received clearance from the US Food and Drug Administration (FDA) for the O₂VENT device, an oral appliance intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnoea (OSA).

The O₂VENT is a 3D-printed titanium mandibular (jaw) advancement device fitted in a patient’s mouth. It has an airway that directs air to the back of the throat and bypasses nasal, soft palate and tongue obstructions. It was developed in 2014 by Oventus founder and dentist Dr Chris Hart with the help of CSIRO.

The device already is registered with the Therapeutic Goods Administration (TGA) in Australia and is generating revenue for the company. A recent clinical study showed the O₂VENT is successful in treating OSA and that snoring was either eliminated or significantly reduced in 100% of patients — including people who had nasal obstructions and mainly breathed through their mouths, even when they were asleep.

“The recent clinical data strongly supports its superior performance and clearly demonstrates its effectiveness in treating a range of sleep disorders,” said Dr Hart. “It also improves oxygen levels for patients.

“It means a greater number of patients who are CPAP [continuous positive airway pressure] intolerant, or mild to moderate sufferers of sleep apnoea, now have an alternative treatment option available.”

The FDA clearance validates the company’s technology as it prepares to target an international audience — including the ~50 million US adults who currently suffer from snoring or sleep apnoea. Oventus Managing Director and CEO Neil Anderson said the clearance marks “an important milestone for us as we strive to bring our innovative product portfolio to the global market”.