+7 8412 20-58-24
Penza, 1B Centralnaya str., building 2
Penza, 1B Centralnaya str., building 2
NATURAL PROTECTION
OF THE BRAIN
NATURAL PROTECTION OF THE BRAIN
Biological prosthesis of dura mater "xenoDURA"
It´s a natural collagen prosthesis that is equivalent to the human dura mater. The product is a highly purified biological matrix based on collagen and elastin of xenogenic origin. The matrix acts as a tissue-engineering scaffold for fast migration, colonization with the patient’s own cells and physiological regeneration of the dura mater. The prosthesis “xenoDURA” is indicated for repairing of the dural defects, secure sealing with subsequent replacement with the patient’s own tissue. The product consists of highly purified raw materials of animal origin that have passed strict veterinary control. The safety and efficacy of the prosthesis have been confirmed by numerous preclinical tests and clinical trials. The manufacturing process includes a patented stage of deep physiological purification through supercritical fluid extraction. The “smart” processing makes it possible to obtain a matrix with preserved native structure of architectonic proteins, that is maximally free from cells and immunogenic agents. We do not use any toxic cross-linking agents in the manufacturing process. The product undergoes bioresorption and involves into the metabolism in line with the natural laws, gradually being replaced by the patient’s own dura mater. In addition, a special treatment of the raw material prevents any damage to the collagen fibers of the dense native serous layer, and its adhesion with the brain.
- the prosthesis is made using a unique technology of deep physiological purification of raw materials
- it is highly biocompatible and non-immunogenic
- due to its unique properties, it reliably seals the defect and prevents liquorrhea
- it acts as a tissue engineering scaffold for the cells’ migration and physiological regeneration of the patient’s dura mater
- the prosthesis is a scaffold for the growth of fibroblasts and blood vessels
- the prosthesis is highly resistant to cutting by a surgical thread, due to its ultraporous structure and rapid biointegration, it tightly seals the seams and does not leave any traces of punctures after the stitching.
- it is easy to hydrate, trim and stich
- the product has a wide range of sixes that meet the requirements of any plastic intervention
The prosthesis is intended for use by qualified professionals in neurosurgery to replace defects and restore the integrity of the dura mater. Indications for the use of the prosthesis are determined by the operating surgeon in accordance with the established diagnostic and treatment practices.
Indications for use:
◦ to close defects of the brain dura mater:
—after removal of tumors;
—for closing CSF fistulas.
— in decompressive craniectomies with increased intracranial pressure;
◦ to close defects of the spinal cord dura mater:
— after removal of tumors of the spinal cord;
— after spinal cord injuries;
— in decompressive operations on the spine and spinal cord.
Contraindications
It is prohibited to use the dura mater prosthesis:
◦ in infected areas
◦ for replacement of connective tissue under conditions of mechanical tension (the prosthesis is to be fixed to the edges of the dura mater defect without tension)
◦ to replace the vascular wall or myocardium
◦ if a patient has hypersensitivity to collagen of animal origin
The prosthesis can be used in combination with surgical suture material, titanium mesh, biological glues, cements for cranioplasty, hydrogen peroxide, hemostatic sponges.
Indications for use:
◦ to close defects of the brain dura mater:
—after removal of tumors;
—for closing CSF fistulas.
— in decompressive craniectomies with increased intracranial pressure;
◦ to close defects of the spinal cord dura mater:
— after removal of tumors of the spinal cord;
— after spinal cord injuries;
— in decompressive operations on the spine and spinal cord.
Contraindications
It is prohibited to use the dura mater prosthesis:
◦ in infected areas
◦ for replacement of connective tissue under conditions of mechanical tension (the prosthesis is to be fixed to the edges of the dura mater defect without tension)
◦ to replace the vascular wall or myocardium
◦ if a patient has hypersensitivity to collagen of animal origin
The prosthesis can be used in combination with surgical suture material, titanium mesh, biological glues, cements for cranioplasty, hydrogen peroxide, hemostatic sponges.
The prosthesis is supplied sterile in a double-barrier packaging and a cardboard box. It remains sterile within the expiration date indicated on the labels, providing the requirements to transportation and storage are observed.
ATTENTION! DO NOT USE THE PROSTHESIS IF THE PACKAGING IS DAMAGED OR AFTER THE EXPIRY DATE.
A nurse with non-sterile hands opens the cardboard box, cuts the seal and removes the secondary package from the cardboard box.
Then she checks the batch number and prosthesis dimensions on the label of the double-barrier packaging against the corresponding data on the label (seal) of the cardboard box.
ATTENTION! IF THE BATCH NUMBER AND/OR PROSTHESIS DIMENSIONS DO NOT MATCH, DO NOT USE THE PRODUCT.
A nurse with non-sterile hands opens the secondary package (gas permeable pouch), separates the seal and, holding the product by the secondary package, gives it to the surgical nurse with sterile hands.
A surgical nurse with sterile hands opens the primary package (foil pouch) with the product and removes it with the tweezers.
Place the prosthesis in a 0.9% sodium chloride solution for at least 5 minutes. Make sure that the prosthesis is fully submerged into the 0.9% sodium chloride solution to prevent the appearance of unhydrated areas. After the hydration process, the surgeon trims the dura prosthesis to shape with the sterile scissors, making sure that it covers the defect with the least possible tension. The prosthesis is placed with the fibrous (fleecy) side out. Then the prosthesis is fixed along the perimeter with non-absorbable sutures and can be additionally fixed with fibrin glue.
The quality of implantation in the postoperative period can be monitored using computed tomography (CT) or magnetic resonance imaging (MRI).
In rare cases, when it is necessary to remove the prosthesis, the operation is performed under general anesthesia. After careful separation of the surrounding tissue, the prosthesis can be removed, the surgical wound cleaned of any inflamed or infected tissue, and the prosthesis replaced.
Precautions:
avoid damaging the surface of the prosthesis with sharp or hard instruments;
exclude contamination and contact of the prosthesis with substances that, after implantation, can cause embolism and adverse reactions in the body;
exclude drying (including thermal drying under surgical lamps) of a hydrated prosthesis during suturing by constant wetting with sterile saline;
in case of accidental contact of the prosthesis with a non-sterile surface, its further use is prohibited.
ATTENTION! DO NOT USE THE PROSTHESIS IF THE PACKAGING IS DAMAGED OR AFTER THE EXPIRY DATE.
A nurse with non-sterile hands opens the cardboard box, cuts the seal and removes the secondary package from the cardboard box.
Then she checks the batch number and prosthesis dimensions on the label of the double-barrier packaging against the corresponding data on the label (seal) of the cardboard box.
ATTENTION! IF THE BATCH NUMBER AND/OR PROSTHESIS DIMENSIONS DO NOT MATCH, DO NOT USE THE PRODUCT.
A nurse with non-sterile hands opens the secondary package (gas permeable pouch), separates the seal and, holding the product by the secondary package, gives it to the surgical nurse with sterile hands.
A surgical nurse with sterile hands opens the primary package (foil pouch) with the product and removes it with the tweezers.
Place the prosthesis in a 0.9% sodium chloride solution for at least 5 minutes. Make sure that the prosthesis is fully submerged into the 0.9% sodium chloride solution to prevent the appearance of unhydrated areas. After the hydration process, the surgeon trims the dura prosthesis to shape with the sterile scissors, making sure that it covers the defect with the least possible tension. The prosthesis is placed with the fibrous (fleecy) side out. Then the prosthesis is fixed along the perimeter with non-absorbable sutures and can be additionally fixed with fibrin glue.
The quality of implantation in the postoperative period can be monitored using computed tomography (CT) or magnetic resonance imaging (MRI).
In rare cases, when it is necessary to remove the prosthesis, the operation is performed under general anesthesia. After careful separation of the surrounding tissue, the prosthesis can be removed, the surgical wound cleaned of any inflamed or infected tissue, and the prosthesis replaced.
Precautions:
avoid damaging the surface of the prosthesis with sharp or hard instruments;
exclude contamination and contact of the prosthesis with substances that, after implantation, can cause embolism and adverse reactions in the body;
exclude drying (including thermal drying under surgical lamps) of a hydrated prosthesis during suturing by constant wetting with sterile saline;
in case of accidental contact of the prosthesis with a non-sterile surface, its further use is prohibited.
In a comparative study of the physical and mechanical parameters of the “xenoDURA” prosthesis and a commercial substitute widely used in the hospitals, an assessment of the tensile stress at break and thread retention strength was carried out in accordance with the requirements of GOST R ISO 7198-2013. The results are presented in the diagrams. No significant differences were found.
The study involved samples with the same parameters of length, width and thickness. The tests of cutting a prosthesis by a thread were carried out under physiological conditions on an Instron BioPuls 5944 universal testing machine using a 4/0 polypropylene surgical suture material. Tests were also carried out using threads with a thickness of 6/0, 5/0, however, during the tests, the thread tore, not the prosthesis.
The study involved samples with the same parameters of length, width and thickness. The tests of cutting a prosthesis by a thread were carried out under physiological conditions on an Instron BioPuls 5944 universal testing machine using a 4/0 polypropylene surgical suture material. Tests were also carried out using threads with a thickness of 6/0, 5/0, however, during the tests, the thread tore, not the prosthesis.
The ultrastructure of the prosthesis is as close as possible to the structure of the native dura mater and is identical to the substitute widely used in clinical practice. The composition contains collagen, the structure is fibrous, the predominant orientation of the fibers relative to the dominant plane is parallel. The thickness of the fibers is from 1 to 3.5 microns, the distance between the fibers is from 15 to 40 microns. Due to the presence of a natural interfiber space and the porous structure of the fleecy surface, the recipient cells penetrate between the collagen layers of the product, producing a new extracellular matrix, completely replacing the tissues, while the serous side serves as a barrier and prevents tissue integration towards the arachnoid.
To evaluate the biocompatibility of images of the prosthesis “xenoDURA”, we carried out research on stem cell cultures with the registration of the following parameters:
Study of the cytotoxicity of evaluated samples of biomaterials in vitro
Study of proliferative activity of cells cultivated on the surface of evaluated samples of biomaterials in vitro
Study the dynamics of the number of cellular populations cultivated on the surface of evaluated samples of biomaterials in vitro
Samples of the prosthesis do not demonstrate cytotoxicity, both after 24 hours and after 96 hours of cultivation on the surface of samples of diploid fibroblasts and mesenchymal stromal cells of human bone marrow. The number of dead cells when cultivating on these samples did not significantly differ from the number of dead cells when cultivating on culture dishes (spontaneous cellular death) and was in the range of 3 ± 2 % of the total number of cells.
For diploid fibroblasts and mesenchymal stromal cells of the human bone marrow, cultivated on samples of the “xenoDURA” prosthesis, mitotic activity was comparable with mitotic activity of the same cells cultivated on culture dishes (reference).
The dynamics of the number of two cell populations cultivated on the samples of the “xenoDURA” prosthesis was comparable to each other during the first three days, after which some differences were observed. From the sixth day, the increase in the number of cells did not occur.
The study results demonstrated excellent biocompatibility properties of the “xenoDURA” prosthesis, the product is not cytotoxic and serves as a favorable substrate for stem cell growth.
Study of the cytotoxicity of evaluated samples of biomaterials in vitro
Study of proliferative activity of cells cultivated on the surface of evaluated samples of biomaterials in vitro
Study the dynamics of the number of cellular populations cultivated on the surface of evaluated samples of biomaterials in vitro
Samples of the prosthesis do not demonstrate cytotoxicity, both after 24 hours and after 96 hours of cultivation on the surface of samples of diploid fibroblasts and mesenchymal stromal cells of human bone marrow. The number of dead cells when cultivating on these samples did not significantly differ from the number of dead cells when cultivating on culture dishes (spontaneous cellular death) and was in the range of 3 ± 2 % of the total number of cells.
For diploid fibroblasts and mesenchymal stromal cells of the human bone marrow, cultivated on samples of the “xenoDURA” prosthesis, mitotic activity was comparable with mitotic activity of the same cells cultivated on culture dishes (reference).
The dynamics of the number of two cell populations cultivated on the samples of the “xenoDURA” prosthesis was comparable to each other during the first three days, after which some differences were observed. From the sixth day, the increase in the number of cells did not occur.
The study results demonstrated excellent biocompatibility properties of the “xenoDURA” prosthesis, the product is not cytotoxic and serves as a favorable substrate for stem cell growth.
Recommendations in the postoperative period depend on the surgical diagnosis and do not have features associated with the use of the prosthesis. As with all patients undergoing brain surgery, careful monitoring and prevention of external or hidden liquorrhea and infectious complications is recommended in accordance with clinical guidelines.
The warranty period of the product is 2 years from the date of manufacture and corresponds to the “Use by” date indicated on the labels. After the expiration date, the product must be disposed of.
Effectiveness
To evaluate the effectiveness and performance of the “xenoDURA” prosthesis, preclinical studies were carried out on large laboratory animals (sheep) using the model of orthotopic implantation. As a reference sample we used a substitute product that has a wide application in clinical practice. The samples were implanted in the area of the formed defect in the native dura mater.
After three months of implantation, identical results were obtained.
After three months of implantation, identical results were obtained.
«xenoDURA»
Histological examination showed no inflammatory reaction. Active processes of biointegration and vascularization were noted. From the side of the cranial vault - active formation of coarse fibrous connective tissue, as well as foci of osteoid. The dura mater that is directly adjacent to the area of implantation was not pathologically changed.
Histological picture of the “xenoDURA” prosthesis after 90 days of implantation:
Histological examination showed no inflammatory reaction. Active processes of biointegration and vascularization were noted. From the side of the cranial vault - active formation of coarse fibrous connective tissue, as well as foci of osteoid. The dura mater that is directly adjacent to the area of implantation was not pathologically changed.
Histological picture of the “xenoDURA” prosthesis after 90 days of implantation:
Reference sample
There is no inflammatory response. Active processes of biointegration and vascularization are noted, moreover, with weak signs of biodegradation of the prosthesis. From the side of the cranial vault - active formation of coarse fibrous connective tissue, osteoid foci are detected.
There is no inflammatory response. Active processes of biointegration and vascularization are noted, moreover, with weak signs of biodegradation of the prosthesis. From the side of the cranial vault - active formation of coarse fibrous connective tissue, osteoid foci are detected.
