Sinus implants

SINUVA™ (mometasone furoate) sinus implant

<p>The SINUVA™ sinus implant treats chronic rhinosinusitis (CRS) with nasal polyps via targeted drug delivery.</p>

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Features

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Proven to shrink nasal polyps1

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Reduces sinus obstruction and improves impaired sense of smell1

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Reduces symptoms of nasal obstruction and congestion1

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Treatment with SINUVA™ resulted in fewer patients still needing sinus surgery1

Key benefits of SINUVA™

SINUVA™ is a novel implant with a 2-in-1 mechanism that offers patients with nasal polyps symptom relief via:

- Targeted delivery of 1350 µg of mometasone furoate to the ethmoid nasal polyps2

- Self-expanding, bioabsorbable design that softens over time2

How the SINUVA™ sinus implant works

  • Continuous delivery of mometasone furoate over the course of 90 days2
  • Localized drug delivery minimizes reliance on patient compliance
  • Administered in a non-surgical, in-office procedure with local anesthesia
  • Mometasone furoate offers high potency and low systemic bioavailability1
Learn about the benefits SINUVA offers to patients.

  

INDICATION

SINUVA™ Sinus Implant is a corticosteroid-eluting implant indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥ 18 years of age who have had ethmoid sinus surgery.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Patients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA™ Sinus Implant. 

WARNINGS AND PRECAUTIONS

Local Nasal Adverse Reactions: Monitor nasal mucosa adjacent to the SINUVA™ Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma.

Glaucoma and Cataracts: Nasal steroids may result in development of glaucoma and/or cataracts. Glaucoma, cataracts, and clinically significant elevation of intraocular pressure were not observed in patients from the treatment group of one randomized controlled clinical study (N = 53) who underwent bilateral placement of SINUVA™ Sinus Implants. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. 

Immunosuppression and Risk of Infections: Persons who are using drugs that suppress the immune system, such as corticosteroids, including SINUVA™ Sinus Implant are more susceptible to infections than healthy individuals. The safety and effectiveness of SINUVA™ Sinus Implant have not been established in pediatric patients less than 18 years of age and SINUVA™ is not indicated for use in this population. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. 

Hypercorticism and Adrenal Suppression: If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.

ADVERSE REACTIONS

The most common adverse reactions observed (> 1% of subjects) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis. 

POST MARKETING EXPERIENCE

The following adverse reactions have been identified during post-approval use of the SINUVA™ sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, epistaxis.

RX only. Please see Full Prescribing Information for SINUVA™.

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† SINUVA™ is removed at day 90 or earlier per physician discretion.

‡ Mometasone furoate nasal spray.

 

PROPEL™ IMPORTANT SAFETY INFORMATION

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.
See full prescribing information (IFU).
Rx only.

 
  1. Kern RC, et al. Int Forum Allergy Rhinol. 2018;8:471-81
  2. SINUVA [Prescribing Information]. Menlo Park, CA: Intersect ENT; 2023.