ABSTRACT
Background
Dural repair products are evolving from animal tissue derived materials to synthetic materials as well as from inert to absorbable features. Biomimicry inspired design will significantly improve growth and regeneration of dural cells and tissues for better repair effects and less complications. We have firstly developed the new absorbable Poly-Llactide (PLLA) dural repair product ReDura based on biomimetic electrospun technology.
Objective
The new product would be characterized with mechanical properties and biocompatibility both in vitro and in vivo and proved to be safety and efficacy in animal and clinical research.
Methods
The microstructure, mechanical properties, and cytotoxicity were evaluated by SEM scanning, tensile testing, and MTT assay, respectively For safety and efficacy evaluation, canine model was used for dural defect repair experiment and subsequent general and histological observations. One completed clinical case was reported here to further evaluate the safety and efficacy of ReDura.
Results
The ReDura patch exhibited unique 3D nonwoven microfibers structure with excellent mechanical strength and good flexibility as well as good biocompatibility. In animal study, complete defect closures and no CFS leakage or nervous system defect were found. Postoperative local inflammatory response was mild and similar to the control groups, indicating that ReDura has good tissue compatibility. In clinical research, there was no CSF leakage post-operation and other clinical observations were normal. The health recover of the patient was good.
Conclusions
The new biomimetic absorbable PLLA dural patch fabricated was confirmed safe and effective, and proved to be an ideal dural alternative substitute.
Keywords: biomimetic, synthetic, absorbable, microfibrous patch, dural repair

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