FDA Approves New Sleep Apnea Implant
Company Says Procedure as Effective as CPAP
WebMD News Archive
More Than Snoring and Sleepiness 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
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
"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."