Sinuva

FDA-approved non-surgical treatment option for nasal polyp sufferers

Every year, more than 500,000 people in the U.S. undergo endoscopic sinus surgery. Unfortunately, about 60% of all patients with chronic sinusitis return with nasal polyps within one year of surgery. Chronic sinusitis patients with nasal polyps complain most often of persistent nasal obstruction/congestion, drainage, facial pain/pressure, and reduced sense of smell. Now these patients have a non-surgical treatment option to shrink nasal polyps thanks to the FDA-approved SINUVA (mometasone furoate) Sinus Implant. SINUVA Sinus Implant is indicated for the treatment of nasal polyps in patients 18+ years of age who have had ethmoid sinus surgery.

Placed during an in-office procedure, SINUVA opens in the ethmoid sinus cavity and releases an anti-inflammatory steroid directly to the polyps for up to 90 days. SINUVA is clinically proven to reduce polyps and nasal obstruction/congestions symptoms. The most common adverse reactions observed in clinical studies were bronchitis, upper respiratory or middle ear infections, headache, lightheadedness, asthma, and nose bleed.

Wake Sinus Center is among the first in the area to offer SINUVA.

INDICATION

SINUVA Sinus Implant is a drug-releasing (mometasone furate) implant indicated for the treatment of nasal polyps, in patients 18+ years of age who have had ethmoid sinus surgery.

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 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 nose bleed.

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 www. SINUVA.com

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