SINUVA® Sinus Implant
SINUVA is a prescription steroid-releasing (mometasone furoate), implantable stent approved by the FDA as an additional therapy option for adult patients who have recurring nasal polyps after ethmoid sinus surgery.
HOW IT WORKS
SINUVA is an innovative technology that reduces polyps and the sensation of nasal congestion and obstruction with a 2-in-1 approach:
- Designed to open in the sinus cavity
- Directly delivers anti-inflammatory medicine to treat nasal polyps
The implant is designed to release medicine over the course of 90 days, gradually softening over time while it is in your sinus.
THE IMPLANTATION PROCESS
SINUVA is not a surgery; it’s a stent inserted into the ethmoid sinus cavity through the nasal opening during a routine office visit. SINUVA usually cannot be felt once it is in place.
The typical procedure takes 30-40 minutes. This includes 10-30 minutes to numb your nose and ~ 5-10 minutes to place the SINUVA implants.
After 90 days, it can be removed or earlier at your doctor’s discretion. Be advised, as the implant softens and polyps decrease, the implant may, in part or in whole, be expelled out of the nose on its own or with actions such as sneezing or forceful nose-blowing. If this occurs, you should notify your ENT physician.
SINUVA was clinically proven to (1,2):
- Shrink nasal polyps at 90 days
- Reduce symptoms of nasal obstruction and congestion
- Improve patients altered sense of smell
- Reduce their need for further sinus surgery
The most common adverse reactions observed in clinical trials were bronchitis, upper respiratory or middle ear infection, headache, light-headedness, asthma, and nosebleed.
IMPORTANT SAFETY INFORMATION
If you have a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, do not use SINUVA. Hypersensitivity reactions, including rash, itch, and swelling have been reported with the use of steroids. If steroid effects such as Cushing Syndrome and adrenal suppression appear, consult your healthcare professional.
SINUVA is made from bioabsorbable polymers designed to soften over time. As the implant softens and polyps decrease, the implant may be expelled out of the nose on its own or with actions such as sneezing or forceful nose blowing. The implant can be removed 90 days after placement or earlier at the physician’s discretion. Repeat administration of SINUVA has not been studied.
As with other endoscopic sinus procedures, there are risks associated with the insertion or removal of SINUVA. SINUVA should be inserted by physicians trained in otolaryngology. Discuss risks related to insertion or removal of SINUVA with your healthcare professional. Your healthcare professional will monitor the nasal tissue adjacent to the SINUVA Sinus Implant for any signs of bleeding, irritation, infection, or perforation. SINUVA should not be used in patients with nasal ulcers or trauma. The most common adverse reactions observed in clinical studies were bronchitis, upper respiratory or middle ear infection, headache, lightheadedness, asthma, and nosebleed.
If you experience excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat, immediately contact a healthcare professional. Close monitoring is recommended if you have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts.
You may report side effects to your physician or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Intersect ENT at 1-866-531-6004. RX Only. For important risk and use information about SINUVA, please see Full Prescribing Information or visit www.SINUVA.com.
1. SINUVA Prescribing Information, Intersect ENT. December 2017
2. Kern RC, Stolovitzky JP, Silvers SL, et al. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol.2018;8:471–81.