FDA Approves New Sleep Apnea Implant

Company Says Procedure as Effective as CPAP

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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: 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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