Cerafix Dura Substitute is a novel non-biologic graft that is indicated for the repair of dural defects. A synthetic, porous polymer matrix, Cerafix works to eliminate cerebrospinal fluid leakage and prevent post-surgical wound complications2.
In addition to preventing cerebral spinal fluid leakage, Cerafix has the additional benefit of supporting new tissue ingrowth. In cases where dural closure is critical to a successful surgical outcome, Cerafix has been shown to support healing and prevent leakage without the risks involved with biologics, such as the transmission of diseases or the risk of adverse reactions to foreign material.
Designed based on the scale and stucture of human extracellular matrix (ECM), Cerafix offers a unique alternative to existing dural substitutes with distinct advantages that may improve patient outcomes.
1,2Novel nanofabricated dura substitute effectively repairs dural defects independent of defect size in a canine duraplasty model
Cerafix Dura Substitute device safety and efficacy has not been evaluated for pediatric and pregnant patients.
Suturing is not required, but if desired, Cerafix can be sutured in place with tensionless suture material.
Cerafix has a two-year shelf life from the packaging date when stored at ambient temperatures. Refer to the expiration date on the product box for details. Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
No, there is no specific orientation required for application. Apply with either side to the brain.
Cerafix is indicated for defects of 4.9 in2 (31.7 cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.