Propel mometasone furoate implant

Image of Propel steroid-eluting stent next to Propel Mini.

Propel mometasone furoate implant (trade name Propel), is a bioabsorbable steroid-eluting stent developed by Intersect ENT. It is implanted after surgery to assist in treating chronic rhinosinusitis.[1] It delivers steroids over a 30 day period prior to dissolving, and has been shown to improve outcomes of surgery.[2][3][4]

Propel uses sustained release technology to deliver mometasone furoate directly to the sinus mucosa.[5][6] The device is inserted into an open surgical cavity. The device has what is described as a "spring-like design,"[7] which conforms to a patient's sinus anatomy and props open the sinus cavity.[5] Anti-inflammatory medicine is then delivered over a 30 day period with the device dissolving so it does not need to be removed.[6] The use of Propel reduced the need for additional surgical procedures and steroid pills, which can have detrimental side effects. Propel is also manufactured in a smaller version known as the Propel mini.[8]

Efficacy

Image of Propel steroid-eluting stent deployed inside the sinus cavity.

A randomized, double-blind pilot study of Propel using 43 patients during an eight week trial period showed no adverse effects.[9] The intra-patient control design compared a drug-eluting implant (Propel) to a non-steroid eluting implant. It also showed adhesion rates of 5.3% for those using Propel in comparison to 21.1% for those who received a non-steroid eluting implant.[10][11] The trial showed less than 10% of stent material present after 30 days with the remaining completely absorbed by the end of the eight week trial.[10][9]

In 2011, The Laryngoscope published the ADVANCE study on the safety and effectiveness of steroid-eluting implants using the Propel device as supplied by Intersect ENT.[12] The conclusion of the study reported favorable rates of sinus patency, with minimal inflammation and adhesions after 30 days.[13] Patients reported symptom reductions were also collected to 6 months using the Sino-Nasal Outcome Test-22 Questionnaire and Rhinosinusitis Disability Index. The study showed a positive impact of using the device and demonstrated improved patient symptom scores with no evidence of ocular risk.[12]

The ADVANCE II study, a randomized double-blind study, published by the American Academy of Otolaryngology – Head and Neck Surgery in 2012 was evaluated by an independent, blinded panel of surgeons and resulted in a 29% reduction in postoperative interventions and a 52% decrease in lysis of adhesions in all 210 patients involved in the study.[13][14]

A Meta Analysis, published by the International Forum of Allergy and Rhinology in 2012, pooled the efficacy data from the pilot and ADVANCE II studies.[3] This resulted in the first Level 1-A evidence in support of a sinus surgery product.[3] The analysis showed Propel reduces the need for oral steroids by 40%, decreases adhesions by 70%, and decreases the need for post-surgical medical and surgical therapies by 35%.[3]

Approval

It received pre-market approval from the FDA in August 2011 and for Propel mini in November 2012.[10][11]

See also

References

  1. ↑ Leuty, Ron (25 February 2013). "Intersect ENT lands $30M for nasal implants blow out". San Francisco Business Journal. Retrieved 6 December 2013.
  2. ↑ Liang, Jonathan; Lane, Andrew P. (2012). "Topical Drug Delivery for Chronic Rhinosinusitis". Current Otorhinolaryngology Reports 1 (1): 51–60. doi:10.1007/s40136-012-0003-4. PMC 3603706. PMID 23525506.
  3. 1 2 3 4 Bleier, Benjamin S.; Schlosser, Rodney J. (2011). "Endoscopic anatomy of the postganglionic pterygopalatine innervation of the posterolateral nasal mucosa". International Forum of Allergy & Rhinology 1 (2): 113–7. doi:10.1002/alr.20011. PMID 22287329.
  4. ↑ Lee, Jivianne T; Han, Joseph K (2013). "Sinus implants for chronic rhinosinusitis: Technology evaluation". Expert Opinion on Drug Delivery 10 (12): 1735–48. doi:10.1517/17425247.2013.839654. PMID 24088141.
  5. 1 2 Li, Peter F.; Downie, David; Hwang, Peter H. (2009). "Controlled steroid delivery via bioabsorbable stent: Safety and performance in a rabbit model". American Journal of Rhinology and Allergy 23 (6): 591–6. doi:10.2500/ajra.2009.23.3391. PMID 19958608.
  6. 1 2 Kennedy, David W (2012). "The PROPEL™ steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery". Expert Review of Respiratory Medicine 6 (5): 493–8. doi:10.1586/ers.12.53. PMID 23134241.
  7. ↑ "How It Works". IntersectENT. Retrieved 8 December 2013.
  8. ↑ "Intersect ENT Propel mini Bioabsorbable Sinus Implant FDA Cleared". med Gadget. 12 November 2012. Retrieved 7 December 2013.
  9. 1 2 Murr, Andrew H.; Smith, Timothy L.; Hwang, Peter H.; Bhattacharyya, Neil; Lanier, Brent J.; Stambaugh, James W.; Mugglin, Andrew S. (2011). "Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent". International Forum of Allergy & Rhinology 1 (1): 23–32. doi:10.1002/alr.20020. PMID 22287304.
  10. 1 2 3 Fink, Jennifer L. W. (December 2011). "Drug-Eluting Sinus Stent Hits the Market: May help maintain patency after FESS". ENT Today. Retrieved 7 December 2013.
  11. 1 2 Pedersen, Amanda (22 August 2011). "NewCo on the block: Intersect ENT wins PMA for drug-releasing implant". Medical Device Daily. Retrieved 8 December 2013.
  12. 1 2 Forwith, Keith D.; Chandra, Rakesh K.; Yun, Paul T.; Miller, Steven K.; Jampel, Henry D. (2011). "ADVANCE: A multisite trial of bioabsorbable steroid-eluting sinus implants". The Laryngoscope 121 (11): 2473–80. doi:10.1002/lary.22228. PMID 22020898.
  13. 1 2 Kennedy, David; Wei (2012). "Mometasone implant for chronic rhinosinusitis". Medical Devices: Evidence and Research: 75. doi:10.2147/MDER.S33916.
  14. ↑ Marple, B. F.; Smith, T. L.; Han, J. K.; Gould, A. R.; Jampel, H. D.; Stambaugh, J. W.; Mugglin, A. S. (2012). "Advance II: A Prospective, Randomized Study Assessing Safety and Efficacy of Bioabsorbable Steroid-Releasing Sinus Implants". Otolaryngology -- Head and Neck Surgery 146 (6): 1004–11. doi:10.1177/0194599811435968. PMID 22301107.

External links

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