FDA Approves New Sleep Apnea Implant
Company Says Procedure as Effective as CPAP
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
"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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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.
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.