Treatment with the Continuous Positive Airway Pressure, (CPAP), is the first line of treatment for patients with Obstructive Sleep Apnea, OSA. Despite its proven efficacy, significant number of patients cannot tolerate this form of treatment.
Pivot Solution is a custom fitted one piece simple acrylic retainer with a soft inner surface that comfortably engages the upper and lower teeth in the wears mouth and natural bite position. This softer material holds the retainer in place all night. It features a tongue depressor, which is bonded in soft silicone, that pivots during occasional swallowing at night. The innovative tension mechanism allows the tongue depressor to return to its original positon thereby opening the airway without waking the wearer!
The PIVOT SOLUTION device will be indicated as a prescription oral appliance for the treatment of Obstructive Sleep Apnea, OSA and moderate to severe SNORING.
PIVOT SOLUTION does not tether the wearer to a machine all night, like the Continuous Positive Airway Pressure or CPAP machine. PIVOT SOLUTION does not grip the tongue in one stationary position all night and awaken the user whenever swallowing or shifting sleeping positions.
PIVOT SOLUTION does not trigger the gag reflex because it addresses the problem directly by engaging the tongue immediately and gently tucks the tongue down and forward.
PIVOT SOLUTION is inserted while the tongue is fully extended and begins to position the tongue forward as the tongue is retracted, thereby creating an open airway WITHOUT triggering the gag reflex because it never touches any part of the throat.
PIVOT SOLUTION is very easy to adjust to. In the morning the wearer simply removes the retainer, washes it and it's ready to use again at night. Because PIVOT SOLUTION is a simple small oral appliance, it is easy to maintain and travel with. Unlike the unattractive CPAP mask and machine.
The PIVOT SOLUTION allows the wearer to occasionally swallow at night without waking to reposition the appliance!
PIVOT SOLUTION eliminates morning jaw joint pain, headaches and related discomforts associated with mandibular advancement devices, pictured below.
PIVOT SOLUTION does not project the jaw forward as these leading Sleep Apnea appliances do.
One study found that people who suffered from OSA using the CPAP machine may aggravate the airway obstruction in 12% of adult patients who suffered from epiglottis collapse during sleep. The epiglottis is a cartilaginous flap at the top of the larynx. Another study found that 15% of the adult patients are unable to tolerate CPAP have multilevel obstruction.
All oral appliances indicated for OSA and moderate to severe SNORING are mandated to be available by prescription only, not over the counter. The regulatory strategy for this device will be the FDA's 510k process, which will require clinical trials before registration.