Palatal Implants for the Treatment of Obstructive Sleep Apnea or Snoring
Palatal implants are intended to stiffen and change the airflow characteristics of the soft palate tissue (e.g., Pillar® Palatal Implant System). The change has been proposed to reduce the severity of snoring and the incidence of airway obstructions for individuals with mild to moderate obstructive sleep apnea (OSA). The devices are cylindrical shaped segments of braided polyester filaments that is permanently implanted in the soft palate. A delivery tool comprised of a handle and needle assembly allows for positioning and placement of three implants. The procedure is performed under local anesthetic in an outpatient setting.
CPAP is the preferred first-line treatment of obstructive sleep apnea for most patients. A smaller number of patients may use oral appliances as a first-line treatment.
Palatal implants for the treatment of obstructive sleep apnea or snoring is considered investigational.
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The literature on palatal implants consists of three small randomized controlled studies and a few additional case series with medium-term followup. Additional study is needed to determine whether there is a defined subset of individuals who might benefit from this procedure. Studies with longer term follow-up are also needed to evaluate the long-term risk of implant extrusion.
American Academy of Otolaryngology. (2017). Position Statement: Surgical management of obstructive sleep apnea. Retrieved March 22, 2017 from http://www.entnet.org/content/practice-management-resources.
American Academy of Sleep Medicine. (2010) Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Retrieved January 8, 2019 from https://aasm.org/clinical-resources/practice-standards/practice-guidelines/.
BlueCross BlueShield Association. Evidence Positioning System. (1:2019). Surgical treatment for snoring and obstructive sleep apnea syndrome (7.01.101). Retrieved January 8, 2019 from https://evidencepositioningsystem.com/. (28 articles and/or guidelines reviewed)
Choi, J .H. Kim, S. N., and Cho, J. H. (2013). Efficacy of the Pillar implant in the treatment of snoring and mild-to-moderate obstructive sleep apnea: a meta-analysis. Laryngoscope, 123 (1), 269-276. Abstract retrieved June 8, 2015 from PubMed database.
Lee, L., Yu, J., 4, Lo, Y., Chen, N., Fang, T., Huang, C., et al. (2014). Comparative Effects of Snoring Sound between Two Minimally Invasive Surgeries in the Treatment of Snoring: A Randomized Controlled Trial. PLOS One, 9 (5): e97186. (Level 2 evidence)
National Institute for Health and Care Excellence. (2007; last updated 2012, January). Soft-palate implants for obstructive sleep apnoea. Retrieved March 21, 2017 from www.nice.org.uk/guidance/ipg241.
National Institute for Health and Care Excellence. (2007; last updated 2012, January). Soft-palate implants for simple snoring. Retrieved March 21, 2017 from www.nice.org.uk/guidance/ipg240.
U. S. Food and Drug Administration. (2004, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040417. Retrieved July 21, 2010 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2002, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K011723. Retrieved July 21, 2010 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 9/11/2005
MOST RECENT REVIEW DATE: 2/14/2019
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