SINUVA, a nonsurgical targeted nasal polyp treatment

The first and only FDA-approved stent
for the treatment of nasal polyps

What Is SINUVA?
Two in one nasal polyp inflammation sinuva icon

2-in-1 design that expands in the ethmoid sinus and delivers anti-inflammatory medication to reduce nasal polyp inflammation

non-surgical alternative to repeat sinus surgery sinuva icon

Non-surgical alternative to repeat sinus surgery for nasal polyps that can be placed in-office under local anesthesia

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Does not require routine administration of medications, such as injections

SINUVA delivers medication right to the nasal polyps

 

SINUVA is not a
systemic medication

SINUVA is not a surgery; it’s a stent inserted into the ethmoid sinus cavity through the nasal opening during a routine office visit using local anesthesia and delivers anti-inflammatory medication right to the nasal polyps

SINUVA nonsurgical nasal polyps treatment placed in the ethmoid sinus

SINUVA breaks the cycle of current treatment approaches for nasal polyps by providing an effective, localized treatment choice.

Compared to patients that were treated with daily steroid nasal spray alone in a clinical trial*:

Proven to shrink nasal polyps and reduce symptoms of nasal obstruction and congestion for up to 90 days.

Reduced ethmoid sinus obstruction and improved impaired sense of smell compared to patients treated with daily steroid nasal spray alone.

Resulted in fewer patients still needing repeat sinus surgery compared to patients that were treated with daily steroid nasal spray alone.

 

SINUVA is placed in the ethmoid sinus and provides sustained symptom relief for up to 90 days. SINUVA is removed at day 90 or earlier.

nasal polyp patient after sinuva non-surgical treatment standing in sun with dandelion

SINUVA has a proven safety profile

 

Because SINUVA is placed directly amongst the nasal polyps, it is able to provide targeted symptom relief that is sustained up to 90 days, with a low rate of side effects.

SINUVA demonstrated similar local effects and hypersensitivity reactions compared to daily steroid nasal spray, with a low incidence of serious adverse events.

The rates of adverse reactions observed, were similar between SINUVA and patients treated with daily steroid nasal spray.

The most common side effects in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following adverse reactions have been identified during post-approval use of the SINUVA sinus implant: implant migration, lack of efficacy, nasal pain, headache, and nosebleeds.

How does SINUVA work?

SINUVA allows physicians to deliver treatment directly in the ethmoid sinus cavity during a routine office visit.

Find a Physician

Common Questions

How big is SINUVA?

When prepared for the procedure, the stent will be compressed to 7.5mm, a size that is slightly larger than the head of a cotton swab.

How long does the SINUVA procedure take?

In the SINUVA clinical studies, the typical procedure took 30-40 minutes. This includes 20-30 minutes to numb your nose and ~10 minutes to place the SINUVA Implants.

What risks are associated with the placement of SINUVA?

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 nasal polyps shrink 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.

For how long does the medicine in SINUVA work?

SINUVA is designed to deliver anti-inflammatory medicine over the course of 90 days. Approximately 60% of the anti-inflammatory medicine will be delivered in the first 60 days after placement.

Do I need to take other medications with SINUVA?

You should consult with your physician to determine the right treatments to use after the SINUVA procedure.

Does SINUVA require routine office visits?

No. SINUVA will be placed in your sinus without any routine administration required. Your doctor will remove SINUVA 90 days after placement or sooner. Your doctor will inform you of their approach to visits / evaluations between implantation and SINUVA removal.

The SINUVA Sinus Implant is administered in your doctor’s office.

Ask your doctor if SINUVA is right for you.

Download a brochure about SINUVA to help
start a discussion with your doctor.

Download The Guide
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How to get SINUVA

Your insurance could approve SINUVA under either a pharmacy or medical benefit. You will be responsible for any co-pay or co-insurance for both SINUVA and the visit for placement.

Many insurance policies will cover SINUVA.

It is important to check with your insurance provider to ensure that your treatment plan is covered under their policy.

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Connect offers dependable resources to help you seamlessly navigate the payor coverage and reimbursement process.

Find out how to remove the obstacles to treatment with SINUVA

Download Connect Guide
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FIND SINUVA
PHYSICIANS IN YOUR AREA.

Intersect ENT makes information available about physicians that can provide the SINUVA Sinus Implant. Physicians are listed based on the proximity to the zip code that you entered. Intersect ENT does not have any vested interest in any specific physicians, nor do we provide any recommendation, assurance, or guarantee with respect to their service. Intersect ENT does not endorse, recommend, certify, or make any expressed or implied warranty with respect to the credentials, qualifications or abilities of any of these physicians.

Receive more information on how SINUVA can help with your nasal polyps

* 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.

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

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INDICATION

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.

IMPORTANT SAFETY INFORMATION

Who should not use SINUVA?

Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.

What should I tell my doctor before receiving SINUVA?

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.

What are the possible side effects of SINUVA?

  • 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 adverse reactions 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 at www.SINUVA.com/PI

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about SINUVA!

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