ArtiFascia® Brings Superior Sealing and Adherence Capabilities

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