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.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
No large 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. Walker et al. (2006) in a prospective non randomized study of 63 individuals at 5 centers report minimally significant improvement in Apnea Hypopnea Index (AHI) with a very large loss to follow-up.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2010). Surgical treatment for snoring and obstructive sleep apnea syndrome (7.01.101). Retrieved July 13, 2010 from BlueWeb. (27 articles and/or guidelines reviewed)
Main, C., Liu, Z., Welch, K., Weiner, G., Jones, S., & Stein, K. (2009) Surgical procedures and non-surgical devices for the management of non apnoeic snoring: A systematic review of clinical effects and associated treatment costs. Health Technology Assessment, 13 (3), (Level 2 Evidence - Independent Review)
National Guideline Clearinghouse. (2006). Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: An update for 2005. Retrieved July 21, 2010 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence. (2007, November). Soft-palate implants for obstructive sleep apnoea. Retrieved July 21, 2010 from http://www.nice.org.uk/nicemedia/pdf/IPG241Guidance.pdf.
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/cdrh_docs/pdf4/K040417.pdf.
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/cdrh_docs/pdf/K011723.pdf.
Walker, R., Levine, H., Hopp, M., Greene, d., & Pang, K. (2006) Palatal implants: A new approach for the treatment of obstructive apnea. Otolaryngology - Head and Neck Surgery, 135 (4), 549-554. (Level 3 Evidence - Industry Sponsored)
MOST RECENT REVIEW DATE: 9/9/2010
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