The first implantable treatment to prevent sleep apnea has received approval from U.S. regulators, the company that developed the procedure said Tuesday.
Privately held Restore Medical said it received U.S. regulatory clearance to sell the treatment for obstructive sleep apnea, a blockage of the airway that causes a person to stop breathing repeatedly in their sleep.
The implant procedure, already used to treat snoring, involves placing three small woven-polyester inserts into the soft palate at the back of the roof of the mouth. The inserts stiffen the palate to restore air flow.
The treatment is performed in a doctor’s office under local anesthetic.
Alternative to surgery
More than 12 million Americans suffer from sleep apnea, which over time can lead to serious health problems such as high blood pressure and other cardiovascular disease due to low blood oxygen levels.
The most common treatment for the disorder requires a patient to wear a mask over the nose during sleep while an air blower forces air through the nasal passages. Respironics Inc. and ResMed Inc. both make the devices.
Other treatments include dental appliances or surgery to remove adenoids, tonsils or excess tissue.
Harris Nesbitt analyst Joanne Wuensch said it was too soon to tell how many patients who now use air compressors could benefit from a soft palate implant because there are many different causes of sleep apnea.
“It looks like it’s more of an alternative to uvulaplasty, which is a very nasty surgical procedure and is not particularly effective,” said Wuensch.
