INDICATION
SINUVA Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥ 18 years of age who have had ethmoid sinus surgery.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Patients with a known hypersensitivity to mometasone furoate or any of the ingredients in SINUVA should not use SINUVA.
WARNINGS AND PRECAUTIONS
Local Effects: 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.
Ocular Effects: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.
Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids.
Immunosuppression: Patients taking corticosteroids are more susceptible to a more serious or even fatal course of chickenpox or measles than healthy individuals. 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.
There are no studies evaluating repeat implantation of the SINUVA Sinus Implant.
ADVERSE REACTIONS
The most common adverse reactions observed (> 1% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis.
Rx only. Please see Full Prescribing Information. for SINUVA.
Real-World SINUVA Case Study
Dr. Ryan Nord Case Study
This case study is shared as an example of potential outcomes for patients with placement of the SINUVA Sinus Implant. Individual patient outcomes may vary based on the severity of the disease, extent of surgery and patient’s response to treatment. Physicians should use their own judgement when deciding how to treat nasal polyps.
RESOLVE II Study design RESOLVE II was a randomized, controlled, double-blind multicenter study with 300 adult patients diagnosed with chronic sinusitis who had undergone prior bilateral total ethmoidectomy but were indicated for revision endoscopic sinus surgery because they presented with recurrent nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to sinonasal polyposis.
201 patients were assigned to the treatment group and underwent bilateral placement of SINUVA Sinus Implants in the ethmoid sinuses.
The remaining 99 patients were assigned to the control group and underwent a placebo (sham) procedure. The implants were removed at Day 60 to allow blinded grading at Day 90, by three independent sinus surgeons. All patients (treatment and control groups) were required to use a mometasone furoate (200 mcg) nasal spray once daily through Day 90.
Co-Primary endpoints
Patients receiving SINUVA experienced a 74% relative improvement in bilateral polyp grade compared to control at Day 90
- Mean change (SD) for SINUVA -0.56 (1.06) vs -0.15 (0.91) with control (p=0.0073)
- Change from baseline to Day 90 in bilateral polyp grade, as determined by an blinded independent panel graded on an 8-point scale, that represented a sum of 0 (no nasal polyps) to 4 (completely obstructing nasal passage) on both sides
Patients with SINUVA experienced a 30% relative improvement in nasal obstruction/congestion score compared to control at Day 30
- Mean change (SD) for SINUVA -0.80 (0.73) vs -0.56 (0.62) with control (p=0.0074)
- Change from baseline to Day 30 in nasal obstruction/congestion score, as determined by patients, on a scale of 0 (no symptoms) to 3 (severe symptoms)
Most common adverse reactions
The most common adverse reactions observed (in more than 1% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis.
CASE COURTESY OF: Dr. Ryan Nord
VCU Health
SINUVA Placement
- 55 year old female
- 1 previous ethmoid sinus surgery with ASA sensitivity
- Polyp tissue regrowth along ethmoid roof
- Patient treated with budensonide irrigations loratadine, and Montelukast
- Patient reports symptoms of facial pressure, hyposmia and frequent sneezing attacks proir to implant
Two Week Follow-up
- Patient reports decreased facial pressure and nasal crusting
- Bi-lateral nasal polyps reduced compared to prior visit
Two Month Follow-up
- SINUVA removed at this two month follow-up
- Continued reduction in polypoid edema compared to previous visit
- Since placement of SINUVA, patient reports symptoms of facial pressure, hyposmia and frequent sneezing attacks are markedly reduced
Final Result Comparison
Right Ethmoid
Initial Placement
Two Weeks
Two Months
Left Ethmoid
Initial Placement
Two Weeks
Two Months
