Published On: Mon, Mar 5th, 2018

CFDSM receives US FDA approval for innovative treatment for obstructive sleep disorders & snoring

Published On: 12th August 2018
Last Updated On: 13th August 2018

The Center for Craniofacial & Dental Sleep Medicine (CFDSM), a Houston-based company specializing in dental sleep medicine and sleep apnea treatment, announced that it has received FDA clearance on its innovative new treatment for obstructive sleep apnea (OSA) and snoring, The Meridian PM oral appliance.

During sleep, the tongue, muscles of the soft palate and the uvula relax, obstructing the airway leading to sleep disorder breathing. Sleep disorder breathing affects more than 42 million people annually, nationwide. In Houston alone, about 1.2 million people suffer from this disorder each year.

Effects and Traditional Treatments of OSA

OSA is a serious disease that can cause both daytime symptoms like fatigue, poor memory, concentration and performance, and 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 treatments for obstructive sleep apnea offer limited results. CPAP (continuous positive airway pressure) is a common treatment, featuring a mask and a pressurized breathing machine. The CPAP is not monitored, cumbersome, and users often become non-compliant. Many patients stop using the CPAP altogether.

Another common treatment for OSA is the mandibular advancement device (MAD). This 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 opening the airway. Over time, this jaw position can lead to bite changes and jaw joint pain.

Finally, surgery is often the last resort for severe cases of obstructive sleep apnea.

The Meridian PM represents a revolutionary development in oral appliance therapies.

By holding the lower jaw in a more comfortable position, the Meridian PM eliminates the potential jaw pain and changes in the patient’s bite often experienced with traditional oral appliance therapy. It effectively 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. The appliance supports oxygen exchange during sleep, improving 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,” states Cress. “This translates to better access to treatment for people suffering from this potentially dangerous disorder.”

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