SINUVA, a nonsurgical targeted nasal polyp treatment option

The first and only FDA-approved stent for the treatment of nasal polyps for adults who have had ethmoid surgery

DISCOVER RELIEF, THE SINUVA WAY.

Discovering relief with SINUVA

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.

Proven to shrink nasal polyps

Reduced sinus obstruction and improved impaired sense of smell

Reduced symptoms of nasal obstruction and congestion for up to 90 days

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.

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

no injection nasal polyp treatment sinuva icon

No Injections
Does not require routine administration of medications, such as injections

See How it Works

Targeted delivery of mometasone furoate over the course of 90 days

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 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 side effects.

See important safety information.

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.

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

Talk to a doctor who offers SINUVA to see if it’s right for you.

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

Download the Patient Brochure

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.

“connect can help” handshaking icon for sinuva patients’ insurance

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

Find out how to remove the obstacles for how to access 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 location 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

Common Questions

How big is SINUVA?

SINUVA is slightly larger than the head of a cotton swab (7.5 mm) when compressed in preparation for the procedure.

How do I prepare for SINUVA placement?

You don’t need to do anything to prepare for SINUVA placement, but your doctor may provide you with specific instructions prior to the procedure. Talk to your doctor if you have questions.

How long does the SINUVA procedure take?

The whole procedure typically takes less than an hour, usually 30 to 40 minutes. This includes 10 to 30 minutes to numb your nose and about 5 to 10 minutes to place SINUVA.

What risks are associated with the placement of SINUVA?

Insertion of SINUVA has risks similar to other endoscopic sinus procedures. It may also cause local side effects such as nosebleed and injury to nerves or blood vessels in the nose/sinus, serious allergic reactions, weakened immune system, and adrenal insufficiency. The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. During post-approval use of SINUVA, implant migration, lack of efficacy, nasal pain, headache, and nosebleeds, were also identified as side effects.

Will I feel SINUVA in my sinus?

In clinical trials, most patients (over 85%) felt no pain to mild pain/pressure following placement.

How long will SINUVA stay in my sinus?

SINUVA is designed to stay in your sinus and deliver medicine over the course of 90 days. Your doctor will remove SINUVA 90 days after placement or sooner.

Do I need to take other medications with SINUVA?

You should talk with your doctor to determine what treatments you may need following the SINUVA procedure.

For how long does the medicine in SINUVA work?

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.

Do I need to take other medications with SINUVA?

You should talk with your doctor to determine what treatments you may need following the SINUVA procedure.

Does SINUVA require routine office visits?

No. SINUVA will be placed in your ethmoid 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.

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.

§ 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.

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

Indication and Important Safety Information

See More

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?

Serious side effects of SINUVA can include:

  • 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.

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?

Serious side effects of SINUVA can include:

  • 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.

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