CLINICAL
FIRST HUMAN ARTIFASCIA STUDY – COMPLETED
INVESTIGATION TITLE: PROSPECTIVE, SINGLE-CENTER, NON-RANDOMIZED STUDY OF ARTIFASCIA®
IN SUBJECTS REQUIRING DURAL REPAIR FOLLOWING CRANIAL SURGERY
Primary endpoint: CSF leakage and patient safety
Summary of results: CSF leakage was not observed. No device-related adverse event was observed.
NEOART PIVOTAL STUDY – RECRUITING
A PROSPECTIVE, RANDOMIZED, CONTRLLED MULTI-CENTER STUDY OF ARTIFASCIA® DURAL REPAIR
PATCH COMPARED WITH COMMERCIALLY AVAILABLE DURAL SUBSTITUTES
VALIDATION
Burst Strength
Burst Strength of ArtiFascia®
vs Inter Cranial Pressure
Suture Retention Test
Suture Retention Strength of ArtiFascia® vs. Collagen Patch
Tensile Test
Tensile Strength of ArtiFascia®
vs. Collagen Patch
Adherence Strength
Adhesive Strength of ArtiFascia® vs. Collagen Patch
Tensile Test
Sealing features of ArtiFascia® vs. Collagen Patch
Main Conclusions
- ArtiFascia® prevented leakage of saline under different physiological pressures (tested for 30 min.)
- ArtiFascia® demonstrated better suture retention compared to saturable DuraGen®.
- ArtiFascia® showed superior tensile strength as compared to DuraGen®.
- ArtiFascia® showed excellent adherence properties without sutures, when tested on a wet film of collagen under increasing burst pressures (of air).
- ArtiFascia® can withstand pressure of over 90mmHg (saline) before leakage occurs.
