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 for nasal polyps that can be placed in-office under local anesthesia
Does not require routine administration of medications, such as injections
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
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 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.
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.
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.
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.
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.
You should consult with your physician to determine the right treatments to use after the SINUVA procedure.
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.
Download a brochure about SINUVA to help
start a discussion with your doctor.
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.
It is important to check with your insurance provider to ensure that your treatment plan is covered under their policy.
Connect offers dependable resources to help you seamlessly navigate the payor coverage and reimbursement process.
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.
* 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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