Sleep Apnea Implant Approved by FDA

sleep apneaAccording to the National Institutes of Health, approximately 18 million people across the United States suffer from sleep apnea, a condition, which cause them to stop breathing while they sleep. These non-breathing episodes can occur hundreds of times per night and can last for a minute or longer. If left untreated, sleep apnea can cause other serious health problems, such as stroke, high blood pressure, heart disease, diabetes, and depression. As treatment for the condition, many people are forced to wear a continuous positive airway pressure (CPAP) machine while they sleep which forces air through a mask worn over their nose and mouth to prevent them from having non-breathing episodes. However, for a large number of people, the CPAP is ineffective or they simply cannot tolerate the forced air. Therefore, researchers have developed a new device, a sleep apnea implant, which has recently been approved by the Food and Drug Administration (FDA).

The new device, made by Inspire Medical Systems and called upper airway stimulation (UAS), offers patients suffering from moderate to severe obstructive sleep apnea an alternate treatment method. The device is fully implanted in the body and works by delivering a mild stimulation to the patient’s airway, which in turn will help keep the airway open during sleep. Unlike traditional obstructive sleep apnea surgeries that alter a patient’s anatomy by widening his or her airway or removing a portion of the roof of their mouth to enable their airway to stay open during sleep, the UAS device will completely preserve the natural airway and facial anatomy. In addition, researchers say the UAS surgery is both less invasive than other types of sleep apnea surgeries and the recovery time is shorter.

The FDA approved UAS sleep apnea implant device consists of a small generator that is surgically implanted in a patient’s upper chest area much like a pacemaker. The device connects to an electrical lead in the throat that has the ability to sense the patient’s breathing patterns. The lead sends a current, which stimulates the hypoglossal nerve that controls primary airway muscles helping keep them in place so they do not relax and obstruct breathing. The device is controlled by a handheld remote. Patients simply activate it before going to sleep and then turn it off when they wake up.

During clinical trials, researchers surgically implanted the UAS device in 126 patients, 83 percent of which were men, who were suffering from obstructive sleep apnea. On average, the procedure took 140 minutes to complete. Sixteen percent of the trial participants were discharged from the hospital the same day of their procedure while 79 percent were released the following day and five percent went home the second day after their surgery.

Ninety-eight percent of those 126 patients participated in a follow-up 12 months after surgery. From data gathered during the follow-up, researchers were able to prove that the new sleep apnea implant approved by the FDA significantly reduces apnea episodes. Not only does this one of a kind, revolutionary device offer hope to patients who cannot use the CPAP, it also greatly improves their quality of life and lowers their risk of developing other life-threatening diseases.

By Donna W. Martin


Wall Street Journal
American Sleep Apnea Association
New England Journal of Medicine

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