Steroid-Eluting and Non-Steroid-Eluting Sinus Stents
Steroid-eluting sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS) or for treatment of recurrent sinonasal polyposis following ESS. These devices (e.g., PROPEL®, PROPEL® mini, PROPEL® Contour, Sinuva™) are proposed to maintain patency of the sinus openings and/or serve as a local drug delivery vehicle. Reducing postoperative inflammation and maintaining patency of the sinuses may be important in achieving optimal sinus drainage and may impact recovery from surgery and/or reduce the need for additional surgery. Standard management includes topical steroid, packing and irrigation.
The use of steroid-eluting and non-steroid eluting sinus stents for sinus-related conditions, including, but not limited to, the following: postoperative treatment following endoscopic sinus surgery, treatment of recurrent sinonasal polyposis is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
Long-term studies for drug-eluting sinus implants are limited, and the results of comparative studies are conflicting. The evidence for implantable drug-eluting sinus stents in those individuals that experience recurrent sinonasal polyposis is scant, and the risk of bias is very high due to unblinded outcome assessment.
American Academy of Otolaryngology – Head & Neck Surgery. (2015, September). Position Statement: The use of biomaterials in sinonasal procedures. Retrieved June 12, 2017 from http://www.entnet.org.
BlueCross BlueShield Association. Evidence Positioning System. (3:2019). Steroid-eluting sinus stents. (7.01.134). Retrieved May 22, 2019 from https://www.evidencepositioningsystem.com/. (16 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Emerging Technology Evidence Report. (2012, December; last updated March 2017). Steroid-eluting sinus implants (Propel and Propel mini) for maintaining patency after sinus surgery. Retrieved June 12, 2017 from ECRI Institute. (92 articles and/or guidelines reviewed)
Forwith, K. D., Han, J. K., Stolovitzky, J. P., Yen, D. M., Chandra, R. K., Karanfilov, B., Matheny, K. E. (2016). RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. International Forum of Allergy & Rhinology, 6 (6), 573-581. Abstract retrieved October 20, 2016 from PubMed database.
Luong, A., Ow, R.A., Singh, A., Weiss, R.L., Han, J.K., Gerencer, R., et al. (2018). Safety and effectiveness of a bioabsorbable steroid-releasing implant for the paranasal sinus ostia - a randomized clinical trial. JAMA Otololaryngology - Head & Neck Surgery, 144 (1), 28-35. (Level 2 evidence)
Massey, C.J., Suh, J.D., Tessema, B., Gray, S.T., & Singh, A. (2016). Biomaterials in rhinology. Otolaryngology - Head and Neck Surgery, 154 (4), 606-617. Abstract retrieved June 8, 2018 from PubMed database.
National Institute for Health and Clinical Excellence. (2016, March). Interventional procedural guidance: Corticosteroid-eluting bioabsorbable stent or spacer insertion during endoscopic sinus surgery to treat chronic rhinosinusitis. Retrieved October 20, 2016 from https://www.nice.org.uk/guidance/ipg551.
Sedaghat, A.R. (2017). Chronic rhinosinusitis. American Family Physician, 96 (8), 500-506. (Level 2 evidence)
Smith, T. L., Singh, A., Luong, A., Ow, R. A., Shotts, S. D., Sautter, N. B., et al. (2016). Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope, 126 (12), 2659-2664. Abstract retrieved June 8, 2018 from PubMed database.
U. S. Food and Drug Administration. (2011, August). Center for Devices and Radiological Health. Premarket approval decision P100044 (PROPEL™). Retrieved October 20, 2016 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Brief. (2017, August; last update search August 2018). Propel and Propel mini bioabsorbable steroid-releasing sinus implants for treatment of chronic rhinosinusitis in adults. Retrieved May 22, 2019 from www.Hayesinc.com/subscribers. (43 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 6/8/2013
MOST RECENT REVIEW DATE: 8/8/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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