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The first real-world evidence analysis on the impact of the PROPEL family of implants in CRS patients
CMR Publication

The use of PROPEL following sinus surgery may result in payer savings from reduced healthcare resource utilization.

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What Do CRS and Icebergs Have in Common?

HOW DO YOU EVALUATE THE UNDERLYING INFLAMMATORY DISEASE IN PATIENTS WITH CRS? WATCH TO LEARN MORE

ABOVE THE SURFACE IN CRS

Chronic rhinosinusitis (CRS) is a heterogeneous disease, often characterized by the presence (CRSwNP) or absence (CRSsNP) of observable phenotypes like nasal polyps. However, phenotypes don’t necessarily reflect the underlying inflammatory mechanisms.1-3

PHENOTYPES ARE JUST THE TIP OF THE ICEBERG …

CRSwNP symptoms 3d visual CRSwNP symptoms 3d visual
CRSsNP symptoms 3d visual CRSsNP symptoms 3d visual

BELOW THE SURFACE, TYPE 2 INFLAMMATION PREDOMINATES IN CRS

CRS is an inflammatory disease, in which the underlying inflammation is largely characterized as either Type 1, 2, or 3.2,3,6

Chronic rhinosinusitis (CRS) is a heterogeneous disease, often characterized by the presence (CRSwNP) or absence (CRSsNP) of observable phenotypes like nasal polyps. However, phenotypes don’t necessarily reflect the underlying inflammatory mechanisms.1-3

CRS inflammation chart CRS inflammation chart
CRS data key takeaway CRS data key takeaway

FESS, functional endoscopic sinus surgery; IFN, interferon; IL, interleukin; OMC, osteomeatal complex.

*Type 2 inflammation only or a mixture of Type 2 with Type 1 and/or Type 3.

†Study evaluated the association between inflammatory endotypes and clinical presentations in CRS. Patients with CRSsNP (n=121) were compared with patients with CRSwNP (n=134) and markers including IFN-γ (Type 1), eosinophil cationic protein (Type 2), Charcot-Leyden crystal galectin (Type 2), and IL-17A (Type 3) were used to determine inflammatory endotypes.

‡As compared to 17% and 18% of CRSwNP patients have some degree of Type 1 and Type 3 inflammation, respectively.

§As compared to 21% and 27% of CRSsNP patients have some degree of Type 1 and Type 3 inflammation, respectively.

STEROIDS LIMIT TYPE 2 INFLAMMATION

Surgery can help remove inflamed mucosal tissue; however, it does not address the root cause of the disease, and revision surgery is often needed.12 Alleviating persistent inflammation with intranasal steroids (INS) postoperatively is critical for achieving optimal surgical outcomes.13

40%

of CRSwNP patients have recurrence of nasal polyps within 18 months postsurgery12

16%

of CRSsNP patients require revision surgery in a 5-year follow-up14

6X

Disease recurrence post surgery in CRSwNP patients without INS vs with INS, at 1 year15

CRS inflation iceberg CRS inflation iceberg

CONSIDER THE IMPACT OF ORAL STEROIDS

Although oral corticosteroids (OCS) have an established role in postoperative care, and in many cases may be the right treatment for patients with CRS, it’s important to consider its challenges.1,17 Even short courses of OCS have been associated with systemic adverse reactions, especially when administered repeatedly.18

Not all steroids are created equal
Mometasone furoate (MF) is a next-generation corticosteroid designed for improved efficacy and safety.19

The PROPEL sinus implants are indicated to maintain patency and locally deliver steroid to the sinus mucosa in patients ≥18 years of age after sinus surgery: PROPEL for the ethmoid sinus, PROPEL Mini for the ethmoid sinus/frontal sinus opening, and PROPEL Contour for the frontal/maxillary sinus ostia.

Mometasone furoate has not been specifically studied on Type 2 inflammation, but PROPEL has been studied on both patients with CRSwNP and CRSsNP.

PROPEL implants feature an innovative 2-in-1 mechanism that opens the sinuses while delivering MF20-22*

LEARN MORE ABOUT PROPEL

PROPEL is an MF-eluting implant proven to reduce the need for postoperative interventions in CRS patients regardless of nasal polyps23

PROVEN SUCCESS: PROPEL is the only sinus surgery implant clinically proven and supported by Level 1-A evidence to significantly improve outcomes of ethmoid sinus surgery.23

In randomized clinical trials, PROPEL delivered significant reductions in the need for postoperative interventions, REGARDLESS OF NASAL POLYPS, compared to a non-drug implant at Day 30 following ethmoid sinus surgery.23†‡

35% all patients 35% relative reduction
CRSwNP 36% CRSwNP patients 36% relative reduction
CRSsNP 35% CRSsNP patients 35% relative reduction

*The precise mechanism behind the anti-inflammatory properties of the eluted MF is not known.20

†Postoperative interventions was a composite endpoint that included surgical intervention required to separate an adhesion and/or oral steroid intervention to resolve recurrent ethmoid sinus inflammation, edema, and/or polyp recurrence.23

‡Judged by an independent panel.23

Study design: Meta-analysis of two prospective, randomized, double-blinded multicenter studies (Pilot and ADVANCE II) that enrolled 143 patients.23

EXPLORE THE CLINICAL DATA FOR PROPEL

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Instructions for Use:

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Instructions for Use (EU):

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References

  1. Rosenfeld RM, et al. Otolaryngol Head Neck Surg. 2015;152(suppl 2):S1-S39
  2. Akdis CA, et al. J Allergy Clin Immunol. 2013;131(6):1479-1490.
  3. Stevens WW, et al. J Allergy Clin Immunol Pract. 2019;7(8):2812-2820.e3.
  4. Kato A. Allergol Int. 2015;64(2):121-130.
  5. Leung RM, et al. Am J Rhinol Allergy. 2011;25(6):401-403.
  6. Ahern S, et al. Medicina (Kaunas). 2019;55(4). doi:10.3390/medicina55040095.
  7. Fokkens WJ, et al. Rhinol Suppl. 2012;23:3.
  8. Bachert C, et al. Allergy. 2009;64(4): 520-533.
  9. Van Zele T, et al. Allergy. 2006;61(11):1280-1289.
  10. Nagarkar DR, et al. J Allergy Clin Immunol. 2013;132(3):593-600.e12.
  11. Orlandi RR, et al. Int Forum Allergy Rhinol. 2016;6(suppl 1):S22-209.
  12. Deconde AS, et al. Laryngoscope. 2017;127(3):550-555.
  13. Snidvongs K, et al. American Journal of Rhinology & Allergy_2013.
  14. Hopkins C, et al. Laryngoscope. 2009;119(12):2459-2465.
  15. Fandiño M, et al. Am J Rhinol Allergy. 2013;27(5):e146-57.
  16. Gurrola J, Borish L. J Allergy Clin Immunol. 2017;140(6):1499-1508.
  17. Poetker DM, et al. Int Forum Allergy Rhinol. 2013;3(2):104-120.
  18. Waljee AK, et al. BMJ. 2017;357:j1415.
  19. Hochhaus G. Clin Ther. 2008;30(1):1-13.
  20. PROPEL [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2013.
  21. PROPEL Mini [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2016.
  22. PROPEL Contour [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2016.
  23. Han JK, et al. Int Forum Allergy Rhinol. 2012;2(4):271-279.

The PROPEL sinus implants are intended to maintain patency and locally deliver steroid to the sinus mucosa in patients ≥18 years of age following sinus surgery: PROPEL for the ethmoid sinus, PROPEL Mini for the ethmoid sinus/frontal sinus opening, and PROPEL Contour for the frontal/maxillary sinus ostia. Contraindications include patients with confirmed hypersensitivity or intolerance to mometasone furoate (MF) or hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implant in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of the implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For full prescribing information see IFU at www.IntersectENT.com/technologies/. Rx only.

©2022 Intersect ENT, Inc. All rights reserved. Intersect ENT and PROPEL are registered trademarks of Intersect ENT, Inc. in the United States and other countries. MPM-11549 Rev 7.0

The above-identified implants, delivery systems, and/or the use of the above-identified implants/delivery systems in a method may be covered by one or more U.S. and/foreign patents, found at intersectent.com/patents.