Sinuva

 
SINUVA is an innovative technology that reduces symptoms of nasal obstruction and congestion and nasal polyps with a 2-in-1 approach.

-Designed to open in the sinus cavity
-Delivers anti-inflammatory medicine to treat nasal polyps
SINUVA is a nasal polyp treatment without surgery:
Delivered into the sinus cavity through the nasal opening during a routine office visit
Usually cannot be felt once it’s in place
Removed at 90 days or earlier at your doctor’s discretion

How well does SINUVA work?

SINUVA was studied in a clinical trial with 201 patients who received SINUVA and 99 patients who underwent a procedure as a placebo. All patients in the study were diagnosed with chronic sinusitis who had already undergone sinus surgery, but were candidates for revision surgery. Whether they received SINUVA or not, all patients were required to use a nasal spray daily that contained steroids.

SINUVA was proven to shrink nasal polyps and reduce symptoms of nasal obstruction and congestion for up to 90 days. Patients treated with SINUVA had reduced sinus obstruction, reported an improvement in their reduced sense of smell and were less likely to need repeat sinus surgery compared to patients that did not receive SINUVA.

Is SINUVA safe?

The safety of SINUVA was established in 400 patients in 2 clinical trials

-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, upper respiratory or middle ear infection, headache, lightheadedness, asthma, and nose bleed
-Insertion of SINUVA is associated with risks similar to other endoscopic sinus procedures. It may also be associated with local adverse reactions such as nosebleed and injury to nerves or blood vessels in the nose/sinus
-SINUVA is not for people with hypersensitivity to corticosteroids or those with nasal ulcers or trauma

How is SINUVA placed?

SINUVA is placed in your doctor’s office. After numbing your nose, your doctor will insert the SINUVA implant into your nostril on the end of a delivery system, and place the implant within your ethmoid sinus.

Contact a doctor immediately if you experience:
Excessive nasal bleeding or symptoms of infection, such as excessive pain or discomfort, persistent headache, or increased sinus discharge
Symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat
Hypersensitivity reactions, including rashes, itching, and hives
Close monitoring is recommended for patients with a change of vision or a history of increased intraocular pressure, glaucoma, and/or cataracts.