Please rotate your device

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 recess2
  • 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%; P=0.0023; 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.

PROPEL Contour has a PROVEN safety profile1

The safety profile of PROPEL was established across three prospective clinical trials including 205 patients1. The most common adverse reactions observed (≥2% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were acute sinusitis, asthma, headache, chronic sinusitis, upper respiratory tract infection and fungal sinusitis.

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%; P=0.0070; 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 opening

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.

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, which included 80 patients2. The most common adverse reactions observed (≥2% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were sinusitis, headache, epistaxis and bronchitis.

GET PROPEL

Stay Informed

This site is intended for healthcare professionals in the United States

Stay Informed

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. Smith TL, Singh A, Luong A, et al. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016;126(12):2659-2664.
  4. Data on file, Intersect ENT, Inc. PROGRESS CSR R-28020 Rev 4.0 December 28, 2016.