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FDA Approves Sleep Apnea Implant

If you’re one of the estimated 22 million Americans with sleep apnea, you are probably already aware of the lack of comfortable options to treat the condition. From awkward and uncomfortable sleep masks to breathing tubes and oral appliances, many patients choose to simply not wear their apnea device, even though wearing it could save their life.

Sleep apnea is a sleep disorder that causes repeated pauses in breathing during sleep. According to research from the University of Wisconsin, untreated, severe sleep apnea can increase a sufferer’s risk of death by three times the rate of those who don't have the disorder. Worse yet, having sleep apnea can worsen other medical conditions. Data have shown that of the roughly 610,000 people who die of heart disease each year, an estimated 38,000 also had sleep apnea. Having sleep apnea can even increase your risk of hypertension, stroke and heart attack.


But now, there may be some good news for sleep apnea patients who have struggled with traditional sleep apnea devices in the past. This fall, the FDA approved an implantable apnea-controlling device called the Remedē System. The Remedē System works by implanting a battery pack and series of wires into the skin and blood vessels in the upper chest near the phrenic nerve, which is responsible for stimulating the breathing reflex. As the patient sleeps, the Remedē System stimulates the phrenic nerve to move the diaphragm and encourage breathing while it monitors the patient’s respiratory signals.

Dentist Dr. Michele Simpson treats patients with sleep apnea in her Wilmington, North Carolina, clinic. She believes the Remedē System could be a lifesaver for patients who simply won’t wear their current removable devices.

"The devices available today are very safe and effective, but many patients either forget to wear them or don’t want to wear them," she says. "The Remedē System would work well for people who, for whatever reason, aren’t using their prescribed device."

Still, Simpson says not everyone will be a good candidate for the Remedē System. The implant is not designed for patients with obstructive sleep apnea.

"Obstructive sleep apnea occurs when there is a blockage to the upper airway, usually because the patient is overweight or has enlarged tonsils or adenoids," she says. "The Remedē System is designed to stimulate the phrenic nerve. For patients with obstructive apnea, the problem isn’t the phrenic nerve, it's whatever is blocking the airway."

For those patients, Simpson recommends adapting a healthier lifestyle and utilizing a CPAP or orthodontic device to help keep the airway open.

"The hope is, for patients with obstructive apnea, that with surgery or weight loss the apnea may go away on its own. If not, the traditional treatments are very effective, provided the patient actually wears them," she says.

According to the manufacturer, the Remedē System is also not intended for patients who are suffering from infection or for patients who require MRIs.

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