ARTIFASCIA®
Nurami Medical’s ArtiFascia® for dural repair is a porous nanofiber, soft tissue regeneration graft made of medical grade synthetic polymers. The multilayer graft incorporates a novel, temperature-sensitive and visco-elastic sealant, and boasts biodegradable and bioabsorbable functionality. Current dura patches suffer from significant limitations, such as dangerous CSF leaks, which occur in 15% of procedures, risk of disease transmission, adhesions to the brain, cumbersome handling and suturing, poor mechanical properties, and the cost of using both a graft and sealant.
ArtiFascia’s® thickness is comparable to human dura, and it is applied via a routine procedure. ArtiFascia’s® mechanical strength and flexibility enables for robust suturing, convenient handling and pliability that allows the device to conform to the surface of the dural defect without dangerous adhesions while maintaining a mechanical barrier against leakage. The patch degrades naturally over time, and is replaced by the native tissue with complete dural closure.
Nurami Medical’s ArtiFascia® is the first multifunctional nanofiber-based tissue reconstruction patch that combines two functions in a single device
1
The porous nanofiber patch mimics natural extracellular matrices, providing a scaffold, which enables infiltration of fibroblasts and cells from the intact tissue, enhancing tissue regeneration, ultimately replacing damaged dural tissue.
2
The temperature-sensitive and visco-elastic sealant becomes a deformable gel that penetrates suture holes and conforms to fibers, even when stretched. This novel gel eliminates the need for surgical sealants, ensuring watertight sealing of the site, reducing CSF leakage and potentially life-entry of threatening pathogens.
1
The porous nanofiber patch mimics natural extracellular matrices, providing a scaffold, which enables infiltration of fibroblasts and cells from the intact tissue, enhancing tissue regeneration, ultimately replacing damaged dural tissue.
2
The temperature-sensitive and visco-elastic sealant becomes a deformable gel that penetrates suture holes and conforms to fibers, even when stretched. This novel gel eliminates the need for surgical sealants, ensuring watertight sealing of the site, reducing CSF leakage, and potentially life-threatening pathogen entry.
In-vivo testing of ArtiFasciaTM has validated its supremacy over the state of the art, in terms of preventing leakage, mechanical strength, regeneration capabilities, tissue integration, suture retention and more.
