PROPEL MINI SINUS IMPLANT WITH STRAIGHT DELIVERY SYSTEM- kit

Propel Mini Sinus Implant with Straight Delivery System by

Drug Labeling and Warnings

Propel Mini Sinus Implant with Straight Delivery System by is a Other medication manufactured, distributed, or labeled by Intersect ENT, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DEVICE DESCRIPTION

The PROPEL Mini Sinus Implant with Straight Delivery System is a bioabsorbable implant designed to maintain patency of the sinus cavity. The sinus 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. Mometasone furoate 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.

Chemical structure of mometasone furoate

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.

Chemical structure of poly-(DL-lactide-co-glycolide)

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

Chemical structure of polyethylene glycol

The PROPEL Mini Sinus Implant with Straight Delivery System is designed to accommodate the size and variability of the post-surgical ethmoid anatomy. The 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 Mini Sinus Implant with Straight Delivery System is intended for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency of the ethmoid sinus. The PROPEL Mini Sinus Implant separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.

CONTRAINDICATIONS

The use of the PROPEL Mini Sinus Implant is contraindicated in the following patients:

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

WARNINGS AND PRECAUTIONS

WARNINGS

The PROPEL Mini Sinus Implant with Straight Delivery System 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: The Propel sinus implant underwent pharmacokinetics testing. Following bilateral drug-eluting Propel 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 Mini implant.

CARCINOGENICITY, GENOTOXICITY AND REPRODUCTIVE TOXICITY

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

PREGNANCY

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

DOSAGE AND ADMINISTRATION

Each PROPEL Mini 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 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 Mini Sinus Implant with Straight Delivery System include, but may not be limited to:

Premature displacement of implant or implant fragments
Swallowing implant or implant fragments
Pain/pressure/headache may result from the adherence of crusting to, or presence of the implant
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® Mini with Straight Delivery System

Picture of label is representative of label content

PROPEL® Mini with Straight Delivery System
(mometasone furoate implant, 370 µg)

CONTENTS INCLUDE:
One sinus implant (nominal length: 16 mm)
One straight delivery system

Caution: Federal law (US) restricts this product to sale by or on the order of a physician.

Reference Number; 60044	Read Instructions Prior to Use	For Single Use Only
Lot Number 12345678	Sterilized Using Radiation	Contents are STERILE in unopened and undamaged package
Use By; 2025-05-05; yyyy-mm-dd	Store at Room Temperature (15-30° C)

intersect® ENT

4282023 10:15:17
01453 Rev. F

1555 Adams Drive, Menlo Park, CA 94025
Customer Service 1-866-531-6004
CustomerService@intersectENT.com

INGREDIENTS AND APPEARANCE

PROPEL MINI SINUS IMPLANT WITH STRAIGHT DELIVERY SYSTEM 
drug-eluting sinus stent kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:10599-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:10599-004-01	1 in 1 PACKAGE

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		1
Part 2		1

Part 1 of 2

DELIVERY SYSTEM 
drug-eluting sinus stent implant

Product Information
Route of Administration	NASAL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Premarket Application	P100044	01/20/2021

Part 2 of 2

PROPEL MINI SINUS IMPLANT WITH STRAIGHT DELIVERY SYSTEM 
drug-eluting sinus stent implant

Product Information
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)	MOMETASONE FUROATE	370 ug

Inactive Ingredients
Ingredient Name	Strength
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 12000 MW) (UNII: WE369X5600)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Premarket Application	P100044	01/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Premarket Application	P100044	01/20/2021

Labeler - Intersect ENT, INC. (876715355)

Establishment
Name	Address	ID/FEI	Business Operations
Intersect ENT, INC.		876715355	MANUFACTURE