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SINUVA® & PROPEL®


 

If you suffer from chronic sinusitis and/or recurring nasal polyps, Jacksonville ENT Surgery offers our patients advanced surgical and non-surgical solutions! SINUVA is a revolutionary solution to an all too common problem for many. If you’re tired of not being able to breathe, and suffer from constant congestion, this non-surgical procedure could provide some much needed relief.

Jacksonville ENT surgery offers a non-surgical procedure for patients who suffer from repeat nasal polyps with SINUVA™ (mometasone furoate) Sinus Implant. SINUVA is proven to reduce polyps and nasal congestion and obstruction.1

What is SINUVA

SINUVA is a sinus implant that treats nasal polyps without surgery. During a routine office visit, we will use topical and/or local anesthesia to numb the patient’s nose and sinuses. SINUVA is then placed in the sinus cavity through the nasal opening.

How SINUVA works

Its innovative design provides a 2-in-1 approach: it is designed to open in the sinus cavity and release anti-inflammatory medicine to treat nasal polyps for up to 90 days.

SINUVA benefits (At Day 90)2

  • Significantly reduces nasal obstruction and congestion
  • Significantly improves impaired sense of smell


The most common adverse reactions observed in a clinical trial were bronchitis, upper respiratory or middle ear infection, headache, light-headedness, asthma and nose bleed. SINUVA is indicated for adults with nasal polyps who have had ethmoid sinus surgery.

For more information about SINUVA, visit www.SINUVA.com. For education and resources on chronic sinusitis and chronic sinusitis treatment options, visit www.MySinusitis.com.

1SINUVA Prescribing Information, Intersect ENT. December 2017.
2Data on file, Intersect ENT. RESOLVE II Rev. 3.0 CSR R 28017; February 2017.

INDICATION
SINUVA™ Sinus Implant is a drug-releasing (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

If you have a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, do not use SINUVA. Hypersensitivity reactions, including rash, itch, and swelling have been reported with the use of steroids. If steroid effects such as Cushing Syndrome and adrenal suppression appear, consult your healthcare professional.

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. Discuss risks related to insertion or removal of SINUVA with your healthcare professional. Your healthcare professional will monitor the nasal tissue adjacent to the SINUVA Sinus Implant for any signs of bleeding, irritation, infection, or perforation. SINUVA should not be used in patients with nasal ulcers or trauma. The most common adverse reactions observed in clinical studies were bronchitis, upper respiratory or middle ear infection, headache, lightheadedness, asthma, and nose bleed.

If you experience 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, immediately contact a healthcare professional. Close monitoring is recommended if you 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 or visit www.SINUVA.com.

PROPEL represents a medical breakthrough clinically proven to improve surgical outcomes for chronic sinusitis sufferers.1

PROPEL is the first and only device clinically shown to keep the sinuses open after surgery, precisely deliver anti-inflammatory medication directly into the healing tissues, and then dissolve.

The innovative sinus stent decreases post-operative scarring and inflammation, reducing the need for additional surgical procedures as well as oral steroids1 and their potential side effects. At the same time, PROPEL’s spring-like, lightweight design means patients usually cannot even tell that it is there.


1 Han JK, Marple BF, Smith TL et al. IFAR.2012; 2:271-279.

The PROPEL sinus implant is intended for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain the sinus opening. This product is not intended for people who are allergic to the drug (mometasone furoate) or to certain polymers. Safety and effectiveness of the implant in pregnant or nursing females has not been studied. Risks may include pain/pressure, movement of the implant (within or out of the sinus), and possible side effects of the drug. The most common side effects in clinical studies were infection, headache, and nose bleed. For more information on the risks and benefits of PROPEL, please talk to your doctor. The FDA approved labeling can be found at www.PROPELOPENS.com. Rx only. For additional patient information regarding sinusitis, visit: www.MySinusitis.com.

©2016 Intersect ENT, Inc. All rights reserved. INTERSECT and PROPEL are trademarks and registered trademarks of Intersect ENT, Inc. MySinusitis.com is a trademark of Intersect ENT, Inc.

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