Product Offers Targeted Relieffor Managing Chronic Condition
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Placed during a routine physician office visit, SINUVA expands into the sinus cavity and delivers an anti-inflammatory steroid directly to the site of polyp disease for 90 days. Results from a randomized clinical trial demonstrated a 63% relative reduction in bilateral polyp grade (a measurement of the extent of ethmoid polyp disease) for patients treated with SINUVA, compared to control.
“SINUVA represents a much-needed breakthrough for the many nasal polyp
sufferers who are seeking an effective treatment,” said
Nasal polyps are inflammatory growths along the lining of nasal passages or sinuses that can cause nasal congestion, infections and loss of sense of smell. Many people with chronic sinusitis and nasal polyps return to their ENT specialist with symptoms within the first year following initial treatment. Approximately 635,000 Americans have had previous sinus surgery and continue to see their ENT physicians for treatment of recurring symptoms.
“For more than a decade
IMPORTANT SAFETY INFORMATION FOR SINUVA (MOMETASONE FUROATE)SINUS IMPLANT
The 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
RX Only. For important risk and use information about SINUVA, please see Full Prescribing Information at www.SINUVA.com.
This release contains forward-looking statements within the meaning of
Sections 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements should not
be read as a guarantee of future performance or results, and may not
necessarily be accurate indications of the times at, or by, which such
performance or results will be achieved. These statements include those
related to the safety, efficacy and patient and physician adoption of
SINUVA. These forward-looking statements are based on Intersect ENT’s
current expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as
a result of these risks and uncertainties, which include, without
limitation the company’s ability to successfully address