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 following neurosurgery.
Nurami Medical achieved all its defined endpoints, with no device-related 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.
*ArtiFascia is for investigational use only
**Clinical and Pre-clinical data on file at Nurami Medical
Burst Strength of ArtiFascia®
vs Inter Cranial Pressure
Suture Retention Test
Suture Retention Strength of ArtiFascia® vs. Collagen Patch
Tensile Strength of ArtiFascia®
vs. Collagen Patch
Adhesive Strength of ArtiFascia® vs. Collagen Patch
Sealing features of ArtiFascia® vs. Collagen Patch