Implantable Sinus Stents and Drug-eluting Implants for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease
Sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS). These devices have been proposed to maintain patency of the sinus openings and for use as a local drug delivery vehicle. Traditionally, postoperative ESS treatments have included saline irrigation, nasal packs, topical steroids, systemic steroids, topical decongestants, oral antibiotics, and/or follow-up surgical sinus cavity debridement.Bioabsorbable drug eluting implants (e.g., PROPEL®, PROPEL® mini, PROPEL® Contour, Sinuva™) are intended to offer local delivery of a sustained release medication, typically but not necessarily a corticosteroid. The implant maintains sinus patency as it slowly softens or dissolves. Other bioresorbable products combine nasal packing and sinus stenting (e.g., MeroPack™, MeroGel®), designed for post-operative hemostasis and wound healing.
The use of implantable sinus stents or drug-eluting implants for postoperative treatment following endoscopic sinus surgery and for 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.
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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. Medical Policy Reference Manual. (2:2018). Implantable sinus stents for postoperative use following endoscopic sinus surgery and for recurrent sinus disease (7.01.134). Retrieved June 8, 2018 from BlueWeb. (20 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology Evidence Report. (2015, February; update March 2017). Steroid-eluting implant for maintaining sinus patency after ethmoid 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.
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.
Matheny, K. E., Carter, Jr., K. B., Tseng, E. Y., & Fong, K. J. (2014). Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: a prospective case series. International Forum of Allergy & Rhinology, 4 (10), 808-815. Abstract retrieved February 23, 2016 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.
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. (2008. March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072891. Retrieved February 2, 2013 from http://www.accessdata.fda.gov.
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). Propel and Propel mini bioabsorbable steroid-releasing sinus implants for treatment of chronic rhinosinusitis in adults. Retrieved June 8, 2018 from www.Hayesinc.cm/subscribers. (43 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 6/8/2013
MOST RECENT REVIEW DATE: 7/12/2018
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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