PROPEL Safety Information

Indications and Intended Use

The PROPEL sinus implant is intended for use following ethmoid sinus surgery to maintain patency. PROPEL mini is intended for use following ethmoid or frontal sinus surgery to maintain patency. The implants are intended for use in patients ≥18 years of age.

PROPEL sinus implants separate mucosal tissues, prevent obstruction by adhesions, and reduce edema, decreasing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.

Contraindications

The use of the PROPEL sinus implants is contraindicated in the following patients:

  • Patients with suspected or confirmed intolerance to mometasonefuroate.
  • Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.

Warnings

  • The PROPEL sinus implant is designed for single patient use only.  Do not reprocess or reuse.
  • Do not use if the package is open or damaged.

Precautions

  • Special care should be taken to avoid bending, twisting or damaging the implant.
  • The implant is not designed to be modified by the physician.
  • The implant is not intended to be compressed and loaded into the delivery system more than two times.
  • The implant must be placed under endoscopic visualization.
  • The implant exhibits no antimicrobial properties.
  • Foreign body reaction may occur as is possible with most surgical adjuncts.
  • In rare instances, the physiochemical condition associated with sinus surgery, both with and without sinus implants or packing, may present a risk of toxic shock syndrome (TSS).
  • Pediatric Use:  The safety and effectiveness of the implant in pediatric patients have not been established.
  • Pregnancy and Nursing Females: The safety and effectiveness of the implant in pregnant or nursing females have not been established.

Drug Information

Mechanism of Action: Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.  The precise mechanism behind the anti-inflammatory properties of the eluted mometasonefuroate is not known.

Pharmacokinetics:  Following bilateral drug-eluting implant placement after sinus surgery for chronic sinusitis and subsequent weekly morning blood sampling for 4 weeks in 5 adult patients, plasma mometasonefuroate concentrations were not quantifiable at any time point.  Mean cortisol concentrations were within normal limits.

Drug Interactions

No drug-drug interaction studies have been conducted with the implant.

Carcinogenicity, Genotoxicity and Reproductive Toxicity

No long term studies in animals have been performed to evaluate the carcinogenic potential of the implant.

Pregnancy

There have been no controlled studies in pregnant women using the PROPEL sinus implant. The PROPEL sinus implant should be used during pregnancy only if the potential benefits justify the potential risk.

Lactation

It is not known if mometasonefuroate is excreted in human milk. Because other corticosteroids are excreted in human milk, the PROPEL implant should be used only if the potential benefits justify the potential risk.

Dosage and Administration

Each PROPEL implant contains 370µg of mometasonefuroate which is gradually released over time.

Potential Adverse Events

Risks associated with the use of the PROPEL sinus implant are anticipated to be similar to those experienced by patients who undergo placement of sinus implants or packing. The risks potentially associated with use of the PROPEL implant are:

  • Premature displacement of implant or small implant fragments out the nares
  • Swallowing implant or implant fragments
  • Adherence of crusting to the implant, resulting in or contributing to sensations of pain/pressure/headache
  • Aspiration of small implant fragments (not observed in clinical trials)
  • Foreign body response, including formation of granulation tissue

Potential risks or side effects associated with intranasal mometasonefuroate include:

  • nasal irritation
  • hypersensitivity reaction
  • intranasal bleeding
  • localized infection (bacterial, fungal or viral) in the nose or pharynx
  • nasal burning
  • nasal dryness
  • susceptibility to secondary infections due to bacteria, fungi or viruses
  • glaucoma/elevation of intraocular pressure
  • cataracts/change in lens opacities
  • headache
  • pharyngitis

Potential risks or general side effects associated with steroids:

  • alteration of the HPA axis including growth suppression
  • immunosuppression
  • hypersensitivity reactions
  • headache
  • epistaxis
  • coughing
  • vomiting
  • candidiasis
  • glaucoma/elevation in intraocular pressure
  • cataracts/changes in lens opacities
  • arthralgia
  • myalgia

Observed Adverse Events in the PROPEL and PROPEL mini Clinical Studies

Adverse events were reported in 3 prospective clincal trials (ADVANCE II, ADVANCE, AND CONSENSUS II) conducted in the United States with 205 pateints and a total of 400 treated ethmoid sinuses.

Adverse events regardless of relationship to implant) reported in ≥2% of patients across the PROPEL clinical trials are displayed in the table below. 


Adverse Events From All Three Clinical Trials (n=205)


Adverse Event
Type


Percent of Patients Reporting

Sinusitis

32.2

Headache

5.4

Epistaxis

2.0

Bronchitis

2.0


Note:
Events were tabulated through day 60 in the feasibility trial and ADVANCE trial, and through day 90 in the ADVANCE II trial.

Additional adverse events were reported in one other prospective clinical trial (PROGRESS Mini cohort) conducted in the United States with 80 patients and 80 treated frontal sinuses.

Adverse events (regardless of relationship to implant) reported in ≥2% of patients in the PROPEL Mini clinical trial are displayed in the table below. 

Adverse Events for Clinical Trial in the frontal sinus (n=80)


Adverse Event 
Type


Percent of Patients Reporting

Acute Sinusitis

15

Chronic Sinusitis

11.3

Headache

11.3

Upper Respiratory Tract Infection

6.3

Epistaxis

5.0

Presyncope

5.0

Acute Otitis Media

3.8

Asthma

3.8

Nasal Congestion

3.8

Eyelid Congestion

2.5

Influenza

2.5

Nasal Polyps

2.5

Nasopharyngitis

2.5

Nausea

2.5


Important Information:
Prior to use, refer to the Instructions for Use supplied with this device for indications, contraindications, side effects, suggested procedure, warnings and precautions.

PROPEL Sinus Implant IFU

PROPEL mini Sinus Implant IFU


Caution:
Federal (USA) law restricts these devices to sale by or on the order of a physician. See package insert for full product information.