FDA Approves New Sleep Apnea Implant

Company Says Procedure as Effective as CPAP

From the WebMD Archives

Sept. 15, 2004 -- Individuals who suffer from obstructive apnea can now sleep more comfortably.

A procedure approved last year by the FDA to reduce snoring is now approved as a new implantable treatment for sleep apnea, a potentially serious condition affecting some 12 million Americans.

Its backers say the implants are an effective alternative to continuous positive air pressure (CPAP) -- the most widely prescribed therapy for obstructive sleep apnea. Yet the new implantable device may be better accepted by patients. Nearly half of patients who try CPAP stick with it. They often complain that the masks are uncomfortable. CPAP uses a large extension hose and various types of head gear, which are attached to a machine that continuously forces air into the nose. It helps keep the airways open by forcing air into a collapsed airway.

"I tried CPAP, but didn't like the feeling of being hooked up to a machine all night," Chicago sleep apnea patient Paul Younan, tells WebMD. "And the surgical options that were explained to me didn't seem much more advanced than leech treatments. I was told I wouldn't eat for two weeks and I would be in extreme pain, and there was only about a 50% chance that surgery would be effective."


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More Than Snoring and Sleepiness

Instead, three months ago Younan underwent a minimally invasive office procedure where three small, woven-polyester inserts were implanted into the roof of his mouth or the soft palate. Younan is among the first 50 patients in the U.S. to have the implants placed for treating obstructive sleep apnea. They are all taking part in an ongoing study sponsored by the company that developed the procedure, Restore Medical.

Known as the Pillar Procedure, the implants are designed to stiffen the soft palate, which collapses and can cause airway obstruction in four out of five sleep apnea patients.

Obstructive sleep apnea results in airflow blockage, usually due to the collapse of soft tissue in the rear of the throat. People with the condition may stop breathing hundreds of times each night, and breathing can be interrupted for a minute or more. Loud snoring and daytime sleepiness are the most widely reported symptoms, but the condition has been shown to contribute to heart disease, including high blood pressure, heart attack, and stroke.

Continued

The woven inserts are less than an inch long and are implanted under local anesthesia in a doctor's office. Company vice president of commercial operations John Foster tells WebMD that the procedure costs between $1,200 and $2,000 -- roughly the same as a CPAP device but much less than surgery.

Restore's studies indicate that it can help as many as 80% of patients with obstructive sleep apnea, Foster explains.

"This is a minimally invasive, essentially pain-free procedure that we see as a first-line alternative to CPAP, but it can also be used in combination with other treatments," he says.

'More Study Needed'

American Sleep Apnea Association executive director Ed Grandi says it is too early to tell if the procedure will live up to the company's claims for the treatment of obstructive sleep apnea. The FDA approval for the condition was based on European studies, and Grandi says more studies are needed within the U.S.

He notes that CPAP and orally placed devices, which are becoming more popular, are very effective sleep apnea treatments, but patient compliance is a problem with both.

"In general having another treatment modality that is not CPAP or an oral appliance would be a good thing, but the company is just beginning to report on the effectiveness of this procedure for sleep apnea."

Younan is scheduled for a sleep evaluation later this month to assess the procedure's impact on his obstructive sleep apnea, but his own research shows it has been highly effective. The 33-year-old software engineer has been monitoring his snoring each night with the aid of a digital voice-activated recorder.

"Prior to having the procedure I would hear the choking noises and the struggling to breathe, but by about the third week after having it, I began to notice a decline in these noises," he says. "Last night I started the recorder, and the only thing I heard this morning when I played it back was the alarm clock. And my wife says I am as quiet as a sleeping baby now."

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Sources

SOURCES: News release, Restore Medical, St. Paul, Minn. Ed Grandi, executive director, American Sleep Apnea Association. John Foster, senior vice president, commercial operations, Restore Medical. Paul Younan, patient, Chicago.

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