SINUVA is the first and only FDA-approved stent for the treatment of nasal polyps in adult patients who have already had ethmoid sinus surgery.
*Anti-inflammatory medicine (mometasone furoate) was not detected 14 days after placement of SINUVA in a pharmacokinetics study.
SINUVA is an option for the treatment of nasal polyps that’s been shown to provide effective relief, compared to daily steroid nasal spray† alone in a clinical trial with 300 patients.‡
†Mometasone furoate nasal spray.
‡SINUVA was studied in a clinical trial with 201 patients who received SINUVA and daily steroid nasal spray, and 99 patients who were given daily steroid nasal spray alone. All patients were indicated for revision endoscopic sinus surgery at enrollment.
Proven to shrink
nasal polyps
Reduced symptoms of nasal obstruction and congestion for up to 90 days
Reduced sinus obstruction and improved impaired sense of smell
Treatment with SINUVA resulted in fewer patients still needing sinus surgery§
§About 6 out of 10 patients treated with SINUVA and daily steroid nasal spray no longer needed repeat sinus surgery after 90 days compared to about 4 out of 10 patients treated with daily steroid nasal spray alone.
SINUVA offers continuous symptom relief for up to 90 days.
Because SINUVA is placed directly among the nasal polyps, it provides targeted, continuous symptom relief, with a low rate of side effects.
In clinical trials||:
SINUVA demonstrated similar local effects and hypersensitivity reactions compared to daily steroid nasal spray alone
Patients treated with SINUVA and patients treated with daily steroid nasal spray alone experienced similar rates of side effects
The most common side effects were asthma, headache, and nose bleed. The most common side effects observed (in more than 1% of subjects and that occurred more frequently in patients who received SINUVA compared to patients who were given daily steroid nasal spray) in clinical studies were bronchitis, upper respiratory or middle ear infection, headache, lightheadedness, asthma, and nose bleed.
During post-approval use of SINUVA, implant migration, lack of efficacy, nasal pain, headache, and nose bleeds, were identified as side effects.
||The safety of SINUVA was established in 400 patients in 2 clinical trials.
Watch this video to learn about SINUVA
SINUVA is used in adults with nasal polyps who have had ethmoid sinus surgery.
SINUVA targets the underlying sinus inflammation with a 2-in-1 design and 4 easy steps:
SINUVA is inserted into the sinus cavity through the nose during a routine office visit
Expands in the sinus
Delivers anti-inflammatory medicine directly to nasal polyps, not to the rest of the body
SINUVA delivers anti-inflammatory medicine over the course of 90 days
SINUVA is designed to
self-expand and soften over
time
and usually can't be felt once
it's in place
Once placed, SINUVA is designed to stay in your sinus for up to 90 days. Your doctor will remove SINUVA 90 days after placement or sooner
SINUVA is slightly larger than the head of a cotton swab (7.5 mm) when compressed in preparation for the procedure.
SINUVA is designed to deliver anti-inflammatory medicine over the course of 90 days. Based on preclinical animal studies, about 80% of the anti-inflammatory medicine will be supplied in the first 60 days after placement.
No. SINUVA will be placed in your sinus and does not have to be administered routinely. After placement of SINUVA, your doctor will let you know how often he/she will check your progress. Your doctor will remove SINUVA 90 days after placement or sooner.
You should talk with your doctor to determine what treatments you may need following the SINUVA procedure.
SINUVA is the first and only FDA-approved stent for the treatment of nasal polyps
Look to SINUVA. It's not a saline rinse, steroid spray, oral steroid, injectable medication, or sinus surgery
SINUVA has a 2-in-1 design that expands in the sinus and delivers anti-inflammatory medicine directly to the nasal polyps, not to the rest of your body*
SINUVA is placed in-office, and doesn’t have to be taken daily
SINUVA was proven to shrink nasal polyps and reduced symptoms of nasal obstruction and congestion for up to 90 days
SINUVA reduced sinus obstruction
Patients treated with SINUVA reported an improved impaired sense of smell
Resulted in fewer patients still needing repeat sinus surgery compared to patients that were treated with daily steroid nasal spray† alone
*Anti-inflammatory medicine (mometasone furoate) was not detected 14 days after placement of SINUVA in a pharmacokinetics study.
†Mometasone furoate nasal spray.
SINUVA Sinus Implant is a prescription steroid-releasing (mometasone furoate) implant indicated for the treatment of nasal polyps in patients 18 years or older who have had ethmoid sinus surgery.
Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.
Before you receive SINUVA, tell your doctor about all medical conditions you have including nasal/sinus problems (such as nasal ulcers or trauma), eye problems (such as glaucoma or cataracts), or any untreated fungal, bacterial, or viral infections.
Local reactions including nosebleed and injury to nerves or blood vessels in the nose/sinus.
Serious allergic reactions have happened in patients using mometasone furoate including rash, itching or swelling of the lips, face, tongue, and throat, and breathing problems. Call your doctor right away if you have any of these reactions.
Weakened immune system that may increase your risk of infections. Avoid contact with people who have contagious diseases such as chickenpox or measles. Call your doctor right away if you have been near someone with chickenpox or measles.
Adrenal insufficiency
is a condition in which the adrenal glands do not make enough steroid hormones and can cause tiredness, weakness, nausea and vomiting and low blood pressure. Talk to your doctor if steroid effects such as Cushing Syndrome and adrenal suppression appear.
The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following side effects have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, and nosebleeds.
Tell your doctor if you have any side effects that bother you or don’t go away.
Risks related with the insertion and removal of SINUVA are similar to other endoscopic sinus procedures.
SINUVA is made from materials designed to soften over time and may fall out of the nose on its
own as polyps decrease or if you sneeze or blow your nose forcefully. The implant will be removed 90 days after placement or earlier at your doctor’s discretion.
Contact your doctor immediately if you have any changes in vision, 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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information, please see Full Prescribing Information for SINUVA.
Intersect ENT and SINUVA are
registered trademarks of
Intersect
ENT, Inc. in the
United States and other countries.
©2020 Intersect ENT.
All rights reserved.
MPM-11923. Rev. 1.0 12/20
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