Health Problem: Chronic rhinosinusitis (CRS), commonly known as chronic sinusitis, is a condition in which the paranasal sinuses are chronically inflamed, interfering with drainage and causing mucus buildup. Chronic inflammation in sinuses can lead to facial swelling, pain, tenderness, fever, fatigue, and difficulty breathing through the nose. Patients with CRS may require ethmoid sinus surgery (ESS) to help resolve symptoms. The goal of ESS is to open the affected sinus ostia to allow normal sinus drainage while preserving as much bone and mucosal lining as possible. However, ESS outcomes are limited by recurrent inflammation, adhesion formation, and polyp regrowth. A significant number of patients who undergo ESS will later require revision surgery due to recurrent obstructive polyposis.

Technology Description: The Sinuva sinus implant is composed of bioabsorbable polymers that soften over time, eluting mometasone furoate (MF), an anti-inflammatory corticosteroid. The implant is loaded into a proprietary delivery system and placed in the ethmoid sinus under endoscopic visualization by an otolaryngologist. The implant expands in the sinus, where it remains for the elution of MF over a 90-day period. The Sinuva implant may be removed on day 90 or sooner at physician discretion.

Controversy: Intermittent oral steroid therapy is considered an important treatment option for short-term control of inflammation related to nasal polyposis and CRS. However, long-term use of systemic oral steroids is associated with avascular necrosis of the femoral head, osteoporosis, adrenal suppression, hyperglycemia, dyslipidemia, psychiatric disturbances, cardiovascular disease, and immunosuppression. Alternatively, topical steroid treatment is limited by variable and often inadequate penetration of sinus cavities, particularly in anatomical regions where polyps form. More efficient intranasal drug delivery systems are needed to manage CRS with nasal polyps. If proven effective and safe, the Sinuva Sinus Implant may provide patients a less-invasive alternative to revision sinus surgery for recurrent ethmoid polyps. However, the safety and effectiveness of Sinuva are yet to be established.

Key Questions:

  • Is the Sinuva steroid-releasing sinus implant (Intersect ENT Inc.) effective for treating nasal polyps after ESS?

  • How does the Sinuva sinus implant compare with alternative treatments for treatment of nasal polyps after ESS?

  • Is the Sinuva sinus implant safe?

  • Have specific patient selection criteria for the Sinuva sinus implant been established?

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