Material and Structure
• Synthetic biomaterial scaffold resembles microstructures of native dural matrices, and provides appropriate environment for recr-
uitment, growth, and proliferation of dural cells on scaffolds.
• Excellent biocompatible mesh facilitates cellular migration and growth, thus is able to repair and regenerate defective dura within
a few months.
Working Mechanism
• As a repair material, the ReDuraTM patch can effectively address dural defects caused by tumor ablations and traumatic injuries
as well as maintain integrity of anatomical structure of the dura.
• With harmonic pace of degradation and regeneration,scaffold of the patch can be gradually absorbed by human body within a few
months after operation and eventually replaced by new-born dural layers.
• Full degradation and recovery of dural membrane can avoids immuno-rejection of the implanted device caused by long-term exis-
tence of materials.
Patented Technology and Quality Guarantee
• Pending PCT international patent under protection of intellectual property laws and regulations of designed countries.
• Stable mass-production process, effective implementation of ISO13485 Quality Management System.
Pre-clinical Animal Studies: 3-month Post-implantation
• General Appearance
Surgical operation of ReDura
TM patch in a In ReDura
TM groups, new-born membrane
defective dura model took place in defects and scaffold materials
degraded mostly (green arrows);however, in
controls, partial dural was regrown with slow
degradation of scaffold (blue arrows).
• Adhesion Analysis
ReDura
TM group: smooth surface of brain Control group: close adhesion of material
tissue with no adhesion to implanted to brain tissue
material
• Histological Evaluation
ReDuraTMgroup: implant became disconti- Control group: implant was still integrated
nuously distributed and exhibited a loose and strip-shaped; some fibroblasts grew
fine mesh-shaped structure with fibroblast into the implant; a few calcification spots
and collagen fibers growing in a pattern of were seen(in the upper right corner of this
ribbon. picture).
Clinical Studies: ReDuraTM Patches in Patients
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ReDuraTM(4×6cm ) was laid
and sutured onto the dural
of a patient. |
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The patient had glioma. Pre-
operative CT image showed
operative CT image showed
glioma.
|
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Post-operative CT scanning
( Day 3 ). The glioma was
removed and no CSF leakage
was found. |
|
Post-operative CT scanning
(Day7). No CSF leakage was
urther confirmed and rapid
growth of "neo-dural" tissues
was seen. |
