NexStat®

Technical Information


Intended Use:

NexPak® is indicated for use as an intranasal splint intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. NexPak is constructed of a patient-comfortable sponge which is manufactured from 100% plant-based polysaccharides.

Contraindications:

NexPak should not be used on patients who have known allergies to potato starch.

Warnings & Precautions:

• Sterility not guaranteed if package is damaged or opened. Discard damaged or open packages.
• Single Use Only.
• To prevent product contamination prior to application, always follow aseptic techniques.
• Contains: Amylopectin and hydroxyethylcellulose.
• In rare instances, the physiochemical condition associated with nasal surgery, both with and without nasal packing, may present a risk of toxic shock syndrome (TSS).
• NexPak exhibits no antimicrobial properties; it is not bacteriostatic toward pre-existing infections, nor does it prevent the occurrence of new infections. Appropriate treatment to be instituted in case of infection.
• Do Not Ingest.
• Do Not Inhale.
• Do not use after the end of the year and month shown.

Instructions:

1. Peel open NexPak pouch and remove intranasal splint using sterile technique to maintain
product integrity.
2. NexPak may be compressed to conform to nasal anatomy.
3. Insert NexPak longitudinally and apply to area of treatment. For added support, NexPak may be inserted using a bayonet forceps with tips of the forceps advanced to the leading edge of the intranasal splint.
4. If foam is broken during insertion, assess if size is appropriate for application. If not, dispose and re-apply NexPak.
5. NexPak is dissolvable and any residual NexPak that has not dissolved or left the surgical site through normal outflow passages can be removed with irrigation and aspiration.
6. Discard any unused product after opening.


Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. For detailed information regarding indications for use, warnings and precautions, see Instructions for Use.

Content taken from 50085 Rev. B