INDICATIONS AND INTENDED USE
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:
- Separate tissue or structures compromised by surgical trauma.
- Separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery.
- Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
- Act as an adjunct to aid in the natural healing process.
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.
CONTRAINDICATIONS AND WARNINGS
Patients with known shellfish allergies.
WARNINGS
Chitogel Endoscopic Sinus Surgery Kit contains chitosan from shellfish and should not be used in patients with known allergic responses to shellfish. Physicians should test for shellfish allergic response if status unknown, prior to use.
The Chitogel Endoscopic Sinus Surgery Kit should not be used in surgery involving any of the following complications:
- Any form of cerebrospinal fluid leak; or
- Any form of ophthalmic complication, including but not limited to orbital hemorrhage or hematoma and exposure of the orbital tissues.
In rare instances, the physiochemical condition associated with Functional Endoscopic Sinus Surgery (FESS), both with and without material application, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C or more), vomiting, diarrhea, dizziness, fainting (or near fainting when standing up), and/or a rash that looks like a sunburn.
Foreign body reaction may occur as with most surgical adjuvant treatments.
Chitogel Endoscopic Sinus Surgery Kit must be used according to the instructions for use. Read instructions prior to use.