ArtiFascia® Brings Superior Sealing and Adherence Capabilities

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

CLINICAL TRIALS GOV

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 Collagen Patch.
  • ArtiFascia® showed superior tensile strength as compared to Collagen Patch.
  • 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.