Technical Information
Indication:
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.
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™ 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. NexPak™ is dissolvable and can be removed with irrigation and aspiration.
5. Discard any unused product after opening.
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.
• Any residual NexPak™ that has not dissolved or left the surgical site through normal outflow passages may be removed through gentle irrigation and aspiration.
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 50026 Rev. C