SYNTHECEL^® Dura Repair

¹Rosen, Charles L., et al. Results of the Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects. Neurosurgery. 2011 Nov;69(5):1093-103; discussion 1103-4. Control group: Duraform Dural Graft implant (15 units), Duragen II Dural Regeneration Matrix (8 units), Duragen Dural Graft Matrix (10 units), Durepair Regeneration Matrix (2 units), Duragen Plus (1 unit), and Preclude Dura Substitute (1 unit).

Indication Statement

Indications:
SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

Contraindications:
SYNTHECEL Dura Repair must not be implanted in patients who have known allergy or sensitivity to the implant materials (cellulose).

Warnings:
The safety and effectiveness of SYNTHECEL Dura Repair has not been studied in:

Patients that are less than 18 years of age.

Patients who also required use of dural adhesive or sealant.

Patients who had systemic infection (e.g. urinary tract infection, active pneumonia) or evidence of any surgical site infection, fever > 38.3°C (101°F), positive blood culture and/or a positive chest x-ray for acute infectious process.

Patients who were acute cranial trauma surgical cases.

Patients who had chemotherapy and/or radiation treatment within 12 weeks prior to surgery, or had chemotherapy and/or radiation treatment planned 10 weeks post surgery.

Patients who had compromised immune system or autoimmune disease.

Precautions:
SYNTHECEL Dura Repair is provided sterile and should not be re-sterilized. Do not use if packaging or seal has been damaged or opened. SYNTHECEL Dura Repair should be stored at room temperature; must not be frozen (5°C/41°F) or exposed to temperatures above 40°C/104°F. SYNTHECEL Dura Repair is intended for single patient use only. Discard opened or unused product.

Immediately prior to use: remove and discard the protective plastic sheeting from both sides of the device using aseptic technique. Do not allow implant to dry out prior to implantation. Tension should be avoided if suturing the SYNTHECEL Dura Repair. Ensure the edges of the implant are not folded. SYNTHECEL Dura Repair should be used with caution in restricted areas of the skull, (e.g., posterior fossa) due to the potential for local mass effect.

Please refer to the package insert for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Companies products, please contact your local DePuy Synthes Companies representative.

113085-190429 DSUS