Propel

Intersect ENT, INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• DEVICE PROPEL DESCRIPTION
• INDICATIONS FOR USE
• PROPEL CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
  • WARNINGS
  • PRECAUTIONS
  • DRUG INFORMATION
  • DRUG INTERACTIONS
  • CARCINOGENICITY, GENOTOXICITY AND REPRODUCTIVE TOXICITY
  • PREGNANCY
  • LACTATION
• PROPEL DOSAGE AND ADMINISTRATION
• I. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH
• PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Propel
• PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Propel Mini

FULL PRESCRIBING INFORMATION

DEVICE DESCRIPTION

The Propel/Propel ^{Mini sinus implant is a bioabsorbable implant designed to maintain patency of the sinus cavity. The Propel/Propel Mini implant is manufactured from a synthetic bioabsorbable copolymer, poly (L-lactide-co-glycolide) (PLG). The implant contains mometasone furoate (active ingredient), a synthetic corticosteroid with anti-inflammatory activity. Mometasone furoate is a white to off-white powder. The chemical name is 9α,21-dichloro-11β,17α-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C₂₇H₃₀Cl₂O₆, and a molecular weight of 521.43 g/mol. Mometasone furoate is a hydrophobic drug that is practically insoluble in water. Mometasone furoate is stable under aqueous, acidic and oxidative conditions. MF can degrade under extreme basic, thermal and photolytic conditions. The chemical structure is shown. The drug is embedded in a bioabsorbable polymer matrix containing poly-(DL-lactide-co-glycolide) and polyethylene glycol (inactive ingredients) which provides for gradual release of the drug.}

The inactive ingredients on the sinus implant are poly-(DL-lactide-co-glycolide) and polyethylene glycol. Poly-(DL-lactide-co-glycolide) is an amorphous biodegradable polymer. The chemical structure is shown below.

Polyethylene glycol is a hydrophilic polyether compound that is highly flexible. It is non-toxic and non-immunogenic. The chemical structure is shown below.

The implant is designed to accommodate the size and variability of the post-surgical ethmoid sinus anatomy. The Propel/Propel ^{Mini implant is designed to be inserted by a physician under endoscopic visualization and once inserted, the implant is designed to be self-retaining against the mucosa of the surgically enlarged sinus. A delivery system is provided to access the ethmoid sinus and insert the implant.}

INDICATIONS FOR USE

The Propel/Propel ^{Mini sinus implant is intended for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The Propel/Propel Mini implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.}

PROPEL CONTRAINDICATIONS

The use of the Propel/Propel ^{Mini sinus implant is contraindicated in the following patients:}

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

WARNINGS AND PRECAUTIONS

WARNINGS

• •The Propel/Propel ^{Mini 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 mometasone furoate 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 mometasone furoate 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 Propel/Propel ^{Mini implant.}

CARCINOGENICITY, GENOTOXICITY AND REPRODUCTIVE TOXICITY

No long term studies in animals have been performed to evaluate the carcinogenic potential of the Propel/Propel ^{Mini implant.}

PREGNANCY

There have been no controlled studies in pregnant women using the Propel/Propel ^{Mini implant. The Propel ®/Propel® Mini sinus implant should be used during pregnancy only if the potential benefits justify the potential risk.}

LACTATION

It is not known if mometasone furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, the Propel/Propel ^{Mini sinus implant should be used only if the potential benefits justify the potential risk.}

PROPEL DOSAGE AND ADMINISTRATION

Each Propel/Propel ^{Mini sinus implant contains 370µg of mometasone furoate which is gradually released over time.}

I. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Potential Adverse Effects: Potential adverse effects associated with the Propel/Propel ^{Mini sinus implant are anticipated to be similar to those associated with other sinus stents, gels or packing.}

Potential adverse effects associated with the Propel/Propel ^{Mini sinus implant include, but may not be limited to:}

• •Premature displacement of implant or small implant fragments out the nares
• •Swallowing implant or implant fragments
• •Adherence of crusting to 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 mometasone furoate 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

Manufactured by:

Intersect ENT Inc.
1555 Adams Drive
Menlo Park, CA 94025
650-641-2100
www.intersectENT.com

Customer Service 1-866-531-6004
CustomerService@intersectENT.com

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Propel