FDA approves Signifier’s obstructive sleep apnoea device
The FDA has approved Signifier Medical Technologies’ prescription-only device eXciteOSA, which uses electrical muscle stimulation to treat obstructive sleep apnoea (OSA).
In a statement, the regulator said that unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function.
In this case it can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.
OSA is a prevalent sleep-disordered breathing with potential serious long-term effects.
Untreated OSA can lead to serious complications such as heart attack, glaucoma, diabetes, cancer and cognitive and behavioural disorders.
eXciteOSA is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild sleep apnoea for patients who are 18 years or older.
It works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue.
The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between.
It is used for 20 minutes once a day during a wakeful state, for a period of six weeks, and once a week thereafter.
The FDA assessed the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild sleep apnoea.
Using the prescribed treatment regime the percent of time spent snoring at levels louder than 40dB was reduced by more than 20% in 87 out of a cohort of 115 patients.
In a 48-patient subset with snoring and mild OSA, the average AHI reduced by 48%, from 10.21 to 5.27, in 41 out of 48 patients.
The most common adverse events observed were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw.
There are several contra-indications including patients with pacemakers, those with permanent or temporary implants and dental braces.
The eXciteOSA device is not intended for patients who have or are suspected of having more serious cases of OSA.
The FDA reviewed the device through its premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
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