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FDA Clears Implant to Treat Sleeping Disorder PDF Print E-mail
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Written by Newstream   
Sep 16, 2004 at 05:09 AM

September 2004 (Newstream) -- Imagine if you stopped breathing in the middle of the night. Now, imagine doing that hundreds of times a night. The more than 12 million Americans who suffer from sleep apnea don't have to imagine - to them it's real. Sleep apnea is a serious health condition causing constant interruptions from sleep and depriving sufferers from the benefits of deep sleep. While the most common symptoms are snoring and fatigue, the disorder has been linked to heart disease, high blood pressure, stroke and memory problems. But for the first time, sufferers of sleep apnea can avoid painful surgery and life-long treatment options through a simple, one-time, minimally-invasive procedure.

Click here to watch video which looks at a new treatment for obstructive sleep apnea.
The U.S. Food and Drug Administration (FDA) has given Restore Medical the 510 (k) clearance to market the Pillar Procedure, the first implantable treatment cleared by the FDA for Obstructive Sleep Apnea (OSA). OSA is caused by a blockage of the airway usually when the soft tissue in the back of the throat collapses and closes during sleep. As a result, people with untreated sleep apnea repeatedly stop breathing and may wake up 20 to 30 times during the night.

The Pillar Procedure is designed to stiffen the palate to prevent or lessen blockages of the airway. The inserts are 18 mm in length and made from a soft woven polyester - a material used in implantable medical products for more than 50 years. The procedure is conducted in a single, short office setting using local anesthetic and is completely reversible. The Pillar Procedure offers patients a first-line treatment option with minimal pain, short recovery time, and less risk than other surgeries. To find physician in your area or to learn more about this treatment, visit www.restoremedical.com.

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