Oventus receives FDA clearance for its 3D printed oral appliance to treat sufferers of sleep apnoea and snoring
Australian medical device company, Oventus, has received clearance from the U.S. Food and Drug Administration (FDA) for the O2VENTTM device1, an oral appliance intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnoea, OSA. The device is indicated for use during sleep to aid in the treatment of these conditions.
The O2VENT device is a 3D printed titanium mandibular advancement device fitted in the patient’s mouth. It has a unique airway incorporated in the device that directs air to the back of the throat and bypasses nasal, soft palate obstructions and tongue obstructions.
The latest clinical study showed the O2VENT device is successful in treating OSA and that that snoring was either eliminated or significantly reduced in 100 per cent of the patients2. The positive results included those people that had nasal obstructions and consequently were mainly mouth breathers, including when they are asleep.
Oventus founder and clinical director Dr Chris Hart said: “The recent clinical data has shown that the O2Vent is more effective in treating OSA than other oral appliances and has an effect on oxygen levels comparable to CPAP,” said Dr Hart. “It means a greater number of patients who are CPAP intolerant or mild to moderate sufferers of sleep apnoea now have an alternative treatment option available.”
Oventus Managing Director and CEO, Neil Anderson added: “The O2VENT is the Company’s first medical device to receive FDA clearance and is consequently an important milestone for the company as we strive to bring our innovative product portfolio to the global market to benefit the many people that have OSA or snore excessively.”
1 O2VENT is the new brand name for the Oventus Clearway Device which has been on the market in Australia for the past 16 months.
2 Oventus Clinical Trial Report. Data on file.