Duraseal Exact 5mL Spine Sealant System

Indications for Use

The DuraSeal® Exact Spine Sealant System is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.

Contraindications
Do not apply the DuraSeal® hydrogel to confined bony structures where nerves and spinal cord are present since neural compression may result due to hydrogel swelling. The hydrogel may swell up to 12% of its size in any dimension.

Warning
The DuraSeal Xact System has not been studied in:

• Patients with a known allergy to FD&C Blue #1 dye
• Patients with severely altered renal or hepatic function
• Patients who are pregnant or lactating
• Pediatric populations

Do not use the DuraSeal Xact System if an active infection is present at the surgical site.

Cautions

• Use only with Integra® applicators
• The DuraSeal Xact System is provided sterile. Do not use if packaging or seal has been damaged or opened. Do not re-sterilize
• The DuraSeal Xact System is intended for single use only. Discard opened and unused product.
• Do not use if the PEG powder is not free flowing.
• Use within 1 hour of preparing the blue precursor
• Prior to application of the DuraSeal Xact hydrogel, ensure that fluid outflow (CSF, blood) from the target site is suspended.
• Incidental application of the DuraSeal Xact hydrogel to tissue planes that will be subsequently approximated, such as muscle and skin, should be avoided.