FDA Clears Appliance for Obstructive Sleep Apnea Treatment

Richard Gawel

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The Food and Drug Administration (FDA) has cleared the Meridian PM oral appliance from the Center for Craniofacial & Dental Sleep Medicine (CFDSM) for treating obstructive sleep apnea (OSA) and snoring. According to the CFDSM, sleep disorder breathing affects more than 42 million people each year.

Also, OSA can cause daytime symptoms such as fatigue and poor memory, concentration, and performance as well as nighttime symptoms like snoring, insomnia, and frequent awakening. Left untreated, OSA can result in a number of health problems, including high blood pressure, stroke, diabetes, depression, and heart attacks.

Traditional OSA treatments offer limited results, the CFDSM reports. Continuous positive airway pressure (CPAP), which is a common treatment, uses a mask and a pressurized breathing machine. However, CPAP is not monitored, and many users find it cumbersome and don’t comply with treatment, with some stopping altogether, the CFDSM says.

Another common OSA treatment, the mandibular advancement device (MAD), is a customized oral appliance created and modified by a dentist. MADs hold the lower jaw in a forward position, keeping the tongue away from the back of the throat and opening the airway. Over time, the CFDSM says, this jaw position can lead to bite changes and jaw joint pain.

The Meridian PM, though, is designed to hold the jaw in a more comfortable position. It also eliminates the potential jaw pain and changes in the patient’s bite often experienced with traditional oral appliance therapy, the CFDSM says. It treats snoring, OSA, and associated breathing symptoms by stabilizing the lower jaw and training the tongue to stay forward, maintaining a clear upper airway during sleep.

The natural result is a decrease in the frequency and duration of apneic and hypopnea events, including snoring, according to the CFDSM. The Meridian PM supports oxygen exchange during sleep as well, improving the health and social consequences associated with OSA and snoring.

“We tested the Meridian PM against traditional therapies and confirmed that it provides a better, more effective treatment option for OSA,” said CFDSM founder Samuel E. Cress, DDS. “This translates to better access to treatment for people suffering from this potentially dangerous disorder.”

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