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ArtiFascia®

ArtiFascia® is a multilayer, Dural repair graft made of biocompatible and bioabsorbable polymers with integrated barrier layer and  a biomimetic structure of electrospun fibers designed to promote neodura regeneration.

ArtiFascia®, a patented product, is available for commercial use in the USA.

ArtiFascia® has FDA 510(k) clearance.

ArtiFascia
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Unique formulation

Indicated for use in Dural repair, ArtiFascia’s® novel formulation combines 2 external, biomimetic porous scaffolds made of electrospun fibers, that promote Dural regeneration, and an integrated, viscoelastic, barrier layer to protect against Dural repair complications

ArtiFascia’s® morphology and thickness of only 0.4 mm, mimic the morphology and thickness of the native Dura. The graft is customized to offer optimal mechanical properties and timely resorption.

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Advantages

ArtiFascia® provides an innovative solution for Dura repair, through several exceptional features:
Biomimetic, porous scaffold
ArtiFascia® is resorbable and composed of electrospun fibers, which create a biomimetic morphology that promotes neodura regeneration and optimized healing
Biomimetic, porous scaffold
Dual functionality
ArtiFascia®is the only 2-in-1 Dura repair graft combining a porous biomimetic scaffold with a non-porous barrier layer
Dual functionality
Non biological
No animal or human sourced materials, mitigating the risk of disease transmission, as well as sourcing challenges
Non biological
Outstanding usability under wet conditions
Flexible, strong, mechanical features are stable, even under wet conditions
Outstanding usability under wet conditions
Tightens around suture holes
Outstanding suture retention and minimal tearing during application
Tightens around suture holes
Zero major leaks in clinical study
Zero major leaks in clinical study
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Clinical evidence

In a prospective, randomized, controlled, single blind clinical study comparing ArtiFascia® to commercially available dural grafts, ArtiFascia® was found to be non-inferior in terms of CSF leakage rate and other clinical outcomes.

During the 6-month post-operation period, the 58 patients implanted with ArtiFascia® showed:
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Higher usability scores as rated by surgeons*
*Usability scores documented as part of the clinical study.
No CSF leakage in posterior fossa (11 patients implanted with ArtiFascia®)
No device related infections or inflammation
In a non-inferiority clinical study, ArtiFascia showed only 1.7% CSF leakage rate compared to 7.4% in the control group (primary endpoint)

Validation

01
Water permeability test
02
Burst pressure – sutured graft
03
Suture retention
04
Strength and Flexibility
Water permeability test
Mean leakage rates of dural grafts as measured over 5 minutes, under pressure of 8 mmHg (n=3 each group) - ArtiFascia® does not leak and completely seals at physiological CSF pressure.
Burst pressure – sutured graft
Sutured ArtiFascia® holds maximal pressure of 1.7 Psi (88 mmHg)
Suture retention
According to mechanical tests performed in comparison to other products, ArtiFascia® holds sutures better than other suturable products
Strength and Flexibility
ArtiFascia ® is mechanically strong (it has high ultimate tensile strength) but also highly flexible (it can elongate 6 times its original length before breakage)

*Based on comparative testing documented and available upon request.

Intended Use

ArtiFascia® is indicated as a dura substitute for the repair of dura mater. ArtiFascia® is indicated for defects of 25cm2 (3.87 in2) or less in area.
For example, 6 cm X 4 cm (24 cm2) would be an acceptable defect size
ArtiFascia is available in different sizes:
1.2”x1.5”
2”x2”
2.75”x2.75”
1.2”x1.5”
2”x2”
2.75”x2.75”
Science & Technology
Science & Technology
Science & Technology
Nurami Medical develops innovative sealants and surgical grafts for optimal tissue engineering and regeneration based on unique combinations of advanced biomaterials and customized, electrospun nanofiber scaffolds.
Nurami identifies the specific needs of various surgical and wound healing procedures, and develops a proprietary formulation of biocompatible polymers to address these needs.
Electrospun nanofiber scaffolds made of medical grade, resorbable polymers highly resemble the natural extracellular matrix (ECM) creating an ideal biomimetic scaffold for tissue engineering and regeneration. These scaffolds, have tunable porosity, high surface-to-volume ratio and pliability. Electrospun nanofiber scaffolds are poised to become the next generation of surgical patches, offering a different approach to the currently-used animal derived materials.
Product pipeline
Product pipeline
Product pipeline
Nurami’s pipeline includes ArtiFascia®, a Dura repair patch, currently available in the US.

Our next generation adhesive graft/implant ArtiFix® (under development), which can be used as a suture-less dural substitute. ArtiFix® will be especially suitable for spine surgeries and neurosurgeries wherein suturing is challenging, and for additional clinical indications to be developed in the future.  ArtiFix® is based on a novel, integrated, adhesion technique, creating the first degradable adhesive product with the ability to adhere to wet tissues. Currently undergoing pre-clinical studies, ArtiFix® is being designed to provide an effective seal for soft tissue surgeries with outstanding adhesive capabilities, that save time.

Contact us

Israel
USA
Nurami Medical Ltd. HQ
Israel
Nurami Medical Ltd. HQ
36 Ha-Namal St., Haifa, Israel
Nurami Medical INC.
USA
Nurami Medical Inc.
2436 Emrick Boulevard,
Bethlehem, PA 18020, USA
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