ARTIFASCIA®
Watertight dural closure is an important clinical objective, especially in infratentorial procedures. Today, neurosurgeons often use a graft and a liquid sealant to repair the Dura and prevent cerebral-spinal fluid (CSF) leakage after neurosurgeries. Despite this, there is still an up to 30% chance of leakage after surgery. CSF leakage is highly dangerous to the patient and can result in long hospitalization and even require repeating the surgery.
Nurami Medical’s ArtiFascia® for dural repair is a porous nanofiber graft made of medical grade synthetic polymers that is designed to address this problem. The graft incorporates biodegradable nanofibers, to help boost dural regeneration, and a temperature-sensitive, viscoelastic, non-porous barrier film, designed to prevent cerebral-spinal fluid (CSF) leakage. ArtiFascia® helps eliminate the need to use a liquid sealant in addition to the graft while helping to reduce the chance of CSF leakage and helping to enhance patients’ healing and recovery after neurosurgery.
In a multi-center pivotal clinical trial ArtiFasica® was successfully implanted in 58 patients, meeting all endpoints and showing non-inferiority to the tested commercially available alternatives implanted in the control group of 27 patients.
ArtiFascia’s® thickness is comparable to human dura, and it is applied via a routine procedure. ArtiFascia’s® mechanical strength and flexibility enable robust suturing, convenient handling and pliability that allows the device to conform to the surface of the dural defect 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
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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.
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The temperature-sensitive, viscoelastic, non-porous barrier film, becomes a deformable gel that penetrates suture holes and conforms to fibers, even when stretched. This gel helps to eliminate the need for surgical sealants. It was designed to provide watertight sealing of the site, reduce CSF leakage and potentially prevent entry of life-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.
Pivotal clinical trials of ArtiFascia® have shown the product’s safety and ability to prevent leakage. When compared with state-of-the-art alternatives, ArtiFascia scored high in terms of usability, specifically: ease of use, suturing, ease of cutting and product strength.
*ArtiFascia is for investigational use only
