November 1, 2004
Originally Published MDDI November 2004
New Device to Treat Sleep Apnea
FDA has approved the first implantable device for treating obstructive sleep apnea. The Pillar Procedure, developed by Restore Medical Inc. (St. Paul, MN), is a minimally invasive method to place inserts that will help treat those suffering from mild to moderate forms of the disorder.
“Sleep apnea is a huge problem that is as prevalent as diabetes,” says Susan L. Critzer, president and CEO of Restore Medical. “The current solutions involve invasive therapy or lifelong therapy. We offer an alternative for patients who have been unwilling to seek the currently available treatments.”
More than 12 million Americans stop breathing several times during sleep, according to the National Institutes of Health (Bethesda, MD). One to two million people seek medical consultation for some kind of sleep disorder each year, says Critzer. Obstructive sleep apnea occurs when the tissue in the back of the throat collapses and blocks the airway as a result of tissue relaxation during sleep.
“We're the first company to come up with this idea and approach,” says Critzer. “It's a unique application of existing technology.” FDA first approved the Pillar Procedure about two years ago to treat snoring.
The Pillar Procedure uses a palatal implant that helps to prevent airway blockage and reduces the vibration that causes snoring. The method stiffens the structure of the soft palate by placing three inserts, which are less than 1 in. long, in the area. The inserts' porous quality promotes tissue ingrowth and decreases the movement between them and the surrounding tissue. “We've achieved a careful balance of physical properties to allow normal functioning during the day and night,” says Critzer.
The woven polyester inserts are made of a material that has been used in implantable medical products, such as sutures and vascular grafts. “We've taken polyester material and used its properties to make a device that's carefully engineered,” says Critzer. “It doesn't interfere with normal functions, such as speaking or swallowing.” Patients can also begin a normal diet on the same day of the procedure.
Copyright ©2004 Medical Device & Diagnostic Industry
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