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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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YOUR ACTION PLAN FOR THE
FRONTAL SINUS

Factors to consider when selecting your PROPEL tool of choice

  • PROPEL Contour is an hourglass-shaped implant, 8 mm in nominal length, and indicated for the frontal and/or maxillary sinus ostia1
  • PROPEL Contour is optimal for an hourglass-shaped frontal sinus opening

Hourglass-shaped
sinus opening

  • PROPEL Mini is a cylindrical-shaped implant, 16 mm in nominal length, and indicated for the ethmoid sinus and the frontal sinus opening2
  • PROPEL Mini is optimal for cylindrical-shaped frontal sinus openings

Cylindrical-shaped
sinus opening

Patients appropriate for PROPEL Mini or PROPEL Contour

  • ≥18 years of age1,2

  • With and without polyps3,4

  • Undergoing primary or revision ethmoid sinus surgery3,4

  • Frontal sinus surgery by traditional instrumentation, balloon dilation, or a hybrid of both3,4

PROPEL Contour is clinically proven to improve outcomes of frontal sinus surgery3

PRIMARY ENDPOINT: PROPEL Contour delivers significant reduction in the need for postoperative interventions3

65
Relative
reduction

PROPEL Contour reduced the need for postoperative interventions vs surgery alone, at 30 days following frontal sinus surgery (11.5% vs 32.8%; N=80)*†

Significant improvements in occlusion/restenosis in patients who received PROPEL Contour vs Control through Day 90

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

†Judged by an independent reviewer.

SECONDARY ENDPOINTS: PROPEL Contour delivers added benefits to patients3

The benefits of PROPEL Contour in reducing the need for postoperative interventions vs surgery alone following frontal sinus surgery were supported by reductions in occlusion/restenosis, surgical intervention, and inflammation3

RELATIVE REDUCTIONS AT DAY 303

*Judged by on-site clinical investigators. Prespecified and adjusted for multiplicity.

Benefits were also observed in occlusion/restenosis and size of the frontal sinus ostia with PROPEL Contour vs surgery alone through Day 30, as per clinical investigators3

  • 63% relative reduction in occlusion/restenosis

  • 43% greater diameter of the frontal sinus ostia (FSO)
    The FSO diameter of sinus implanted with PROPEL Contour contracted by 24%, as compared to 37% in surgery-only sinuses.

Study Design: The PROGRESS study was an 80-patient prospective, randomized, controlled, blinded clinical trial. The study evaluated outcomes of frontal sinus surgery (using balloons and/or traditional instruments) with PROPEL Contour placement compared to surgery alone, both with standard postoperative care. The study used an intra-patient control design to evaluate clinical outcomes. PROPEL Contour was removed at Day 21 to facilitate blinded independent assessment at Day 30.3

Learn more about the benefits of PROPEL Contour after frontal sinus surgery

For significant improvements to patient outcomes following sinus surgery, add PROPEL Contour to your battle for the frontal sinus

PATIENT A*

Surgery
alone

Day 0

Day 30

surgery+
PROPEL contour

Day 0

Day 30

*Representative outcomes in bilateral sinuses of a single patient from a PROPEL clinical study. Individual results may vary.

frontal case studies

PROPEL Contour has a PROVEN safety profile1

The safety profile of PROPEL Contour was established in the PROGRESS study (Contour Cohort), which included 80 patients.1 The most common adverse reactions observed in ≥2% of subjects were acute sinusitis, asthma, headache, chronic sinusitis, upper respiratory tract infection, fungal sinusitis, nasopharyngitis, nausea, neck pain, sinus headache, and streptococcal pharyngitis.

PROPEL Mini is clinically proven to improve outcomes of frontal sinus surgery2

PRIMARY ENDPOINT: PROPEL Mini delivers significant reduction in the need for postoperative interventions2

38
Relative
reduction

PROPEL Mini reduced the need for postoperative interventions vs surgery alone, at 30 days following frontal sinus surgery (38.8% vs 62.7%; N=80)*†

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

†Judged by an independent reviewer.

SECONDARY ENDPOINTS: PROPEL Mini delivers added benefits to patients3

The benefits of PROPEL Mini in reducing the need for postoperative interventions vs surgery alone following frontal sinus surgery were supported by reductions in occlusion/restenosis, oral steroids, and surgical intervention3

RELATIVE REDUCTIONS AT DAY 303

*Judged by on-site clinical investigators.

Benefits were also observed in inflammation and size of the frontal sinus opening, with PROPEL Mini vs surgery alone at Day 30, as per clinical investigators3

  • 54% reduction in mean occlusion/restenosis
    32% greater diameter of the frontal sinus opening5

Study Design:The PROGRESS study was an 80-patient prospective, randomized, controlled, blinded clinical trial. The study evaluated outcomes of frontal sinus surgery (using balloons and/or traditional instruments) with PROPEL Mini placement compared to surgery alone, both with standard postoperative care. The study used an intra-patient control design to evaluate clinical outcomes. PROPEL Mini was removed at Day 21 to facilitate blinded independent assessment at Day 30.4

Learn more about the benefits of PROPEL Mini after frontal sinus surgery

For significant improvements to patient outcomes following sinus surgery, add PROPEL Mini to your battle for the frontal sinus

PATIENT A*

Surgery
alone

Day 0

Day 30

surgery+
PROPEL Mini

Day 0

Day 30

*Representative outcomes in bilateral sinuses of a single patient from a PROPEL clinical study.

frontal case studies

Optimal treatment following frontal sinus surgery with a full arsenal of options including PROPEL Mini and PROPEL Contour, can help improve patient outcomes

PROPEL Mini has a PROVEN safety profile2

The safety profile of PROPEL Mini was established in the PROGRESS study (Mini Cohort), which included 80 patients.2 The most common adverse reactions observed in ≥2% of subjects were acute sinusitis, chronic sinusitis, headache, upper respiratory tract infection, epistaxis, presyncope, acute otitis media, asthma, nasal congestion, eyelid edema, influenza, nasal polyps, nasopharyngitis, and nausea.

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This site is intended for healthcare professionals in the United States

Instructions for Use:

PROPEL PROPEL MINI PROPEL MINI WITH SDS PROPEL Contour

Instructions for Use (EU):

PROPEL PROPEL MINIPROPEL CONTOUR
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References

  1. PROPEL Contour [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2016.
  2. PROPEL Mini [Instructions for Use]. Menlo Park, CA: Intersect ENT; 2016.
  3. Luong A, Ow RA, Singh A et al. JAMA Otolaryngol Head Neck Surg. 144(1): 28-35, 2018.
  4. Data on file, Intersect ENT, Inc. PROGRESS CSR R-28020 Rev 4.0 December 28, 2016.
  5. Data on file, Intersect ENT, Inc. PROGRESS CSR R-28027 Rev 3.0 November 13, 2015.

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.