ArtiFascia® Pivotal Clinical Trial
In a randomized, multi-center, two-arm, single blind pivotal study carried out at 7 EU medical centers, with a 6-month follow-up period, 58 neurosurgical procedure patients were implanted with ArtiFascia® while 27 control patients were implanted with commercially available, regulatory-approved alternatives.
The objectives of the study were to evaluate the safety, effectiveness and usability of ArtiFascia® in comparison to commercially available Dural repair substitutes repair following neurosurgery.
Nurami Medical achieved all its defined endpoints, with no adverse effects, exhibiting safety of the device and usability. ArtiFascia® scored higher than commercialized, regulatory approved alternatives in various key parameters such as strength of the graft, its suturability, ease of use and ease of cutting the graft down to size.
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.
