Mometasone furoate delivers a combination of potency and safety
Drug Characteristics Comparison1-4
* Lipophilicity numbers normalized relative to triamcinolone acetonide.
† As measured by relative receptor binding affinity compared to dexamethasone, which is set to a value of 100. Higher values designate greater potency.
‡ As measured by plasma concentration of drug from intranasal vs intravenous route.
Mometasone furoate was selected for use in PROPEL™ implant for its sinonasal drug characteristics5:
Highly
lipophilic
Readily absorbs into tissue
Targeted
+ potent
High glucocorticoid receptor affinity
Low systemic bioavailability
Minimizes systemic effects
PROPEL™ implants are clinically proven to maintain patency and to locally deliver mometasone furoate to the sinus mucosa
ETHMOID SINUS: PROPEL™ and PROPEL™ Mini
- PROPEL™ is the only drug-eluting implant supported by the Level 1-A Evidence6
- 35% Relative ReductionII in the need for postoperative intervention6
FRONTAL SINUS: PROPEL™ Contour
- Enhances physician choice: small size, unique hourglass shape, flexible applicator
- 65% Relative ReductionII in need for postoperative intervention7-8
* Postoperative intervention is a composite of need for surgical interventions to separate adhesions and/or need to prescribe oral steroids for inflammation.
† Judged by an independent reviewer or independent panel.
‡ Judged by clinical investigators.
§ Secondary endpoints were not adjusted for multiplicity.
| Secondary endpoints adjusted for multiplicity.
|| All relative reductions Calculated as (T-C)/C as part of adhoc analysis.
Treatment following frontal sinus surgery with a full arsenal of options, including PROPEL™ Mini and PROPEL™ Contour, may help improve patient outcomes.
References
1
Lemke T, Williams D, Roche V, Zito SW, eds. Foye’s Principles of Medicinal Chemistry. 6th ed. Balitmore, MD: Lippincott Williams & Wilkins; 2008.
2
Winkler J, Hochhaus G, Derendorf H. How the lung handles drugs: pharmacokinetics and pharmacodynamics of inhaled corticosteroids. Proc Am Thorac Soc. 2004;1(4):356-363.
3
Sastre J, Mosges R. Local and systemic safety of intranasal corticosteroids. J Invenstig Allergol Clin Immunol. 2012:22(1):1-12.
4
PubChem. Dexamethasone. https://pubchem.ncbi.nlm.nih.gov/compound/Dexamethasone. Accessed June 24, 2019.
5
Hochhaus G. Pharmacokinetic/pharmacodynamic profile of mometasone furoate nasal spray: potential effects on clinical safety and efficacy. Clin Ther. 2008:30(1):1-13.
6
Han JK, Marple BF, Smith TL, et al. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012;2(4):271-279.
7
Luong A, Ow RA, Singh A, et al. Safety and effectiveness of a bioabsorbable steroid-releasing implant for the paranasal sinus ostia: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2018;144(1):28-35.
8
PROGRESS CSR, P500-0514, R28020, Rev 4.0, 28 December 2016.
- PROPEL™ [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2013.
- PROPEL™ Mini [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2016.
- PROPEL™ Contour [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2016.
UC202311005EE MPM – 12527 Rev. 1.0
CRS, chronic rhinosinusitis; MF, mometasone furoate.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at cema.medtronic.com.
PROPEL™ Important Safety Information:
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 sinus ostia in chronic rhinosinusitis patients. Contraindications include patients with 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.co.uk. For use by healthcare professionals only.
Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.
PROPEL™ and PROPEL™ Mini:
PROPEL™ Contour:
