Siesta Medical, Inc. announced September 12 that it had achieved 510(k) clearance for its EncoreTM System. The Encore System is a tongue suspension treatment designed to improve obstructive sleep apnea. According to Siesta Medical, the tongue is implicated in up to 80 percent of obstructive sleep apnea cases, but most sleep apnea surgical treatments do not address the tongue, which is one of the reasons why sleep apnea surgery is not very popular.
The Encore System received 510(k) approval because it was considered to be substantially equivalent to the manufacturer's previous device the Prelude III, which was approved because it was substantially equivalent to the Prelude II, which was approved because it was substantially equivalent to the Prelude. It seems like the first tongue suspension system approved was the Sleep-InTM or Repose bone screw system, approved for treatment of sleep apnea or snoring in 1997. This device also received 510(k) approval because it was deemed to be substantially equivalent to oral appliances used for jaw and tongue advancement.
If you are curious about how the system works, the manufacturer has provided the following informative video:
http://www.siestamedical.com/animations/encore_animation_final.wmv
If you are interested in learning more about your treatment options for sleep apnea, please contact a local sleep dentist today.