Placement of the SINUVA Sinus Implant

The SINUVA Sinus Implant is loaded into a Delivery System and placed in the ethmoid sinus under endoscopic visualization. For the complete instructions on how to place SINUVA, see the Full Prescribing Information.1

Follow these instructions to properly place the SINUVA Sinus Implant in the ethmoid sinus.

  1.  Prepare the patient
  • The patient should be prepared following routine protocols for in-office sinonasal endoscopic procedures1
  • In the clinical study, topical or local anesthetic—such as sprays, pledgets, and cottonoids—was recommended in accordance with protocols for in-office sinonasal endoscopic procedures2
  • In the clinical study, anesthesia injections directly into the middle turbinate or surrounding tissue were used as necessary3
  1. Prepare the implant1
  • Crimp and load the SINUVA implant into the delivery system
  • If necessary, the Implant may be reloaded into the Crimper for a second time
  • NOTE: Do not leave the SINUVA Sinus Implant in the crimped state for more than 5 minutes prior to placement
  1. Place the SINUVA Sinus Implant1
  • Advance the delivery system into the ethmoid sinus cavity
  • During insertion the distal tip should be curved superiorly. Maintain the shaft parallel to the roof of the ethmoid sinus
  • Place the SINUVA Sinus Implant amongst the nasal polyps with the cap oriented toward the posterior ethmoid sinus, and with the Implant positioned as posteriorly and superiorly as possible in the sinus. The long ends of the Implant should be in approximately the 2 o’clock, 4 o’clock, 8 o’clock and 10 o’clock positions

Post-Placement Instructions

Immediately post placement:

  • To adjust the position of SINUVA, use the Seeker on the Delivery System or standard endoscopic surgical instruments
  • Reposition SINUVA if its ends are perpendicular to and in contact with the nasal septum

At the first follow-up appointment, make sure to:

  • Avoid excessive manipulation of the Implant during follow-up, as this can cause dislodgement
    • Avoid coming into contact with the Implant when debriding, or suctioning as to not disturb the positioning or apposition of SINUVA
  • Crusting may be observed; encourage patients to use saline irrigations or sprays regularly

The SINUVA Sinus Implant is made from bioabsorbable polymers designed to gradually soften over time.1
The Implant was designed to gradually release the corticosteroid directly to the nasal polyps over a period of 90 days. The SINUVA Sinus Implant should be removed at day 90 or at any time at the physician’s discretion using standard endoscopic instruments.

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INDICATION

SINUVA™ Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥ 18 years of age who have had ethmoid sinus surgery.

IMPORTANT SAFETY INFORMATION

Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.

SINUVA is made from bioabsorbable polymers designed to soften over time. As the implant softens and polyps decrease, the implant may be expelled out of the nose on its own or with actions such as sneezing or forceful nose blowing. The implant can be removed 90 days after placement or earlier at the physician’s discretion. Repeat administration of SINUVA has not been studied.

As with other endoscopic sinus procedures, there are risks associated with the insertion or removal of SINUVA. SINUVA should be inserted by physicians trained in otolaryngology.

The nasal mucosa adjacent to the SINUVA Sinus Implant should be monitored for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid the use of SINUVA in patients with nasal ulcers or trauma.

The most common adverse reactions observed in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis.

Patients experiencing 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, should immediately contact a healthcare professional.

Close monitoring is recommended if patients have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts.

You may report side effects to your physician or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . You may also report side effects to Intersect ENT at 1-866-531-6004.

RX Only. For important risk and use information about SINUVA, please see Full Prescribing Information.

References: 1. SINUVA Prescribing Information, Intersect ENT. December 2017. 2. Data on File, Intersect ENT. RESOLVE II Protocol, P28017. Version: 2.0; October 2014. 3. Data on file, Intersect ENT. RESOLVE II Rev. 3.0 CSR R 28017; February 2017.

IMPORTANT SAFETY INFORMATION

Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal. Continue Reading

IMPORTANT SAFETY INFORMATION

Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Continue Reading

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