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. The change is intended 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. A delivery tool comprised of a handle and needle assembly allows for positioning and placement of three implants submucosally in the soft palate. The procedure is performed under local anesthetic in an outpatient setting.
POLICY
Palatal implants for the treatment of obstructive sleep apnea or snoring is considered investigational.
No controlled studies were found in the published literature that validate the application of palatal implants for the treatment of obstructive sleep apnea or snoring, or provide comparisons to other treatment.
SOURCES
American Sleep Apnea Association. (2008). Considering surgery for OSA? Retrieved December 5, 2008 from http://www.sleepapnea.org/resources/pubs/osa.html.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2009). Minimally invasive surgery for snoring, obstructive sleep apnea syndrome/upper airway resistance syndrome (7.01.101). Retrieved November 25, 2009 from BlueWeb. (23 articles and/or guidelines reviewed)
Friedman, M., Achalach, P., Lin, H. C., Kakodkar, K. A., Joseph, N. J. & Mazloom, N. (2008). Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngology and Head and Neck Surgery, 138 (2), 209-216. Abstract retrieved December 11, 2008 from PubMed database. (Level 3 Evidence)
Ho, W. K., Wei, W. I., & Chung, K.F. (2004). Managing disturbing snoring with palatal implants: A pilot study. Archives of Otolaryngology--Head & Neck Surgery, 130 (6), 753-758. Abstract retrieved May 5, 2005 from PubMed database. (Level 4 Evidence)
Kuhnel, T. S., Hein, G., Hohenhorst, W., & Maurer, J. T. (2005). Soft palate implants: A new option for treating habitual snoring. European Archives of Oto-rhino-laryngology, 262 (4), 277-280. Abstract retrieved May 5, 2005 from PubMed database.
National Guideline Clearinghouse. (2006). Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: An update for 2005. Retrieved December 5, 2008 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence. (2007, November). Soft-palate implants for obstructive sleep apnoea. Retrieved December 11, 2008 from http://www.nice.org.uk/nicemedia/pdf/IPG241Guidance.pdf.
National Sleep Foundation. (2008). Obstructive sleep apnea and sleep. Retrieved December 11, 2008 from http://www.sleepfoundation.org/site/c.huIXKjM0IxF/b.4814079/k.3F5E/Sleep_and_Obstructive_Sleep_Apnea.htm.
Nordgard, S., Stene, B. K., & Skjostad, K. W. (2006). Soft palate implants for the treatment of mild to moderate obstructive sleep apnea. Otolaryngology Head and Neck Surgery, 134 (4) 565-570. Abstract retrieved February 1, 2007 from PubMed database. (Level 4 Evidence)
U. S. Food and Drug Administration. (2004, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040417. Retrieved December 5, 2008 from http://www.fda.gov/cdrh/pdf4/k040417.pdf.
U. S. Food and Drug Administration. (2002, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K011723. Retrieved December 11, 2008 from http://www.fda.gov/cdrh/pdf/K011723.pdf.
ORIGINAL EFFECTIVE DATE: 9/11/2005
MOST RECENT REVIEW DATE: 1/8/2009
ID_BT
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