Intersect ENT, Inc.

SINUVAStent for Nasal Polyps

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SINUVA is the first and only FDA-approved stent for the treatment of nasal polyps in adult patients 18 years or older who have had ethmoid sinus surgery Are you still living with nasal polyps? Consider an alternative to another sinus surgery — SINUVA is a nonsurgical treatment option that can be placed in office. SINUVA delivers anti-inflammatory medicine directly to the nasal polyps, providing up to 90 days of continuous relief. Once it’s in place, it usually can’t be felt—and you don’t need to remember to take SINUVA daily. SINUVA is designed to stay in your ethmoid sinus until your doctor removes it 90 days after placement or sooner.

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Nasal polyps are soft, non-cancerous (also called “benign”) growths that develop as a result of chronic sinus inflammation.

Symptoms of nasal polyps:

  • Nasal congestion
  • Runny nose/nasal discharge
  • Reduced sense of smell
  • Nasal obstruction
  • Facial pain/pressure

Impact of nasal polyps

Nasal polyp symptoms often make it difficult to breathe and reduce sense of smell, impacting everyday life.

Nasal polyp symptoms, such as nasal discharge and nasal congestion, can hinder and decrease enjoyment in daily activities, and leave patients feeling embarrassed in social situations.

As nasal polyps grow in size and number, they can become large enough to block the nasal passages.

The cycle of traditional nasal polyp treatments

  • Nasal polyp symptoms are often treated with saline rinses and steroid sprays in the nose. However, these treatments must be used daily and don’t always provide relief because it’s difficult for the medicine to reach the polyps. Steroid sprays may be available as generics.
  • Oral steroids are also commonly prescribed for nasal polyp symptoms, and are also available as generics. While steroids have been shown to be effective in treating symptoms, oral steroids don’t specifically target nasal polyps. This means the steroids may circulate in the whole body and with repeated use may cause serious safety concerns, such as high blood sugar levels, infections, bone loss, adrenal suppression, and eye complications.
  • Biologics may also be used for nasal polyps. Biologics are injectable medications, which means that the medication may circulate in your whole body, not just at the nasal polyps. These can also be an expensive option in your treatment journey.

If your current treatment option is only scratching the surface, discover relief with SINUVA

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.

  • Expands in the ethmoid sinus and delivers anti-inflammatory medicine directly to the nasal polyps, not to the rest of your body*
  • Is not a saline rinse, steroid spray, oral steroid, injectable medication, or sinus surgery
  • It does not have to be taken routinely to deliver anti-inflammatory medicine 24/7 for up to 90 days
  • It’s an in-office alternative to repeat sinus surgery for nasal polyps

*Anti-inflammatory medicine (mometasone furoate) was not detected 14 days after placement of SINUVA in a pharmacokinetics study.

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.

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.

SINUVA has a proven safety profile

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.

Who can use SINUVA?
  • SINUVA is used in adults with nasal polyps who have had ethmoid sinus surgery.
How does SINUVA work?
  • 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

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 long will 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.

Does SINUVA require routine administration?
  • 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.
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.

What makes SINUVA unique?
  • 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