Biological information
Acellular matrix products can be used in a wide range of applications, including burns and reconstructive surgery, soft tissue and abdominal wall repair, and as internal implants for orthopedic use in joint surface reconstruction and joint repair. tendons.
The extracellular matrix (ECM) plays an important role in the regenerative process of the tissue. The composition of the ECM includes proteoglycans, hyaluronic acid, collagen, fibronectin and elastin. In addition to providing structural support to cells, some components of the ECM bind to growth factors, creating a reservoir of active molecules that can be rapidly mobilized after damage to stimulate proliferation and migration.
Once placed in the wound bed, the three-dimensional matrix provides a temporary scaffold or support on which cells can migrate and proliferate in an organized manner, leading to tissue regeneration.
Cellular matrices are designed by various chemical and mechanical processes. The ultimate goal is to remove all cellular components using a non-harmful procedure that is able to maintain the structure and function of the original tissue. The more compatible the final product is with the host tissue, the less likely it is to trigger an adverse reaction. The different production phases of each product, however, can degrade the structure of the original tissue or eliminate the growth factors linked to the components of the ECM. This can cause rapid degradation and rapid resorption of the matrix and the formation of scar tissue.
The onset of an adverse reaction can be evidenced by the presence of inflammation with accumulation of cells around the edges of the matrix, which prevents cell or vascular infiltration (encapsulation).
The ideal response is minimal inflammation and gradual degradation of the matrix over time, with full integration into the host tissue. How a product is manufactured is as important as its origin.
Method and duration of storage The storage medium or solution used may affect the stability of the product and the overall shelf life. These characteristics are also affected by the regulatory standards of the individual countries, as well as by the known chemical degradation of the products. The shelf life varies from 18 months to 5 years. Products that have off-the-shelf availability, which can be stored at room temperature and require minimal preparation are beneficial to both physician and patient in terms of preparation time savings and reduced donor site morbidity .
The membrane in the pericardium
B
A
The compact layer forms an impenetrable barrier against bacteria.
Its mechanical characteristics allow immediate positioning of the prosthesis with high resistance to sutures.
The fibrillar layer allows rapid cell settlement which, thanks to the constituents of the ECM, collagen, elastin, hyaluronic acid, fibronectin and proteoglycans accelerate the healing process.
Product description
EXAFLEX pericardium consists of pure bilayer bovine pericardium collagen with multidirectional intertwined fibers.
This collagen is type I, known for its low tendency to cause immunological reactions.
The preparation process tends to eliminate non-collagenic components such as lipids, proteins, enzymes, etc.
The lyophilization process helps to maintain the natural structure of the collagen fibers, allowing optimal integration conditions to the tissues after implantation.
Material safety
EXAFLEX membranes are produced from bovine pericardium.
Materials of bovine origin are considered to be at BSE risk and therefore require a different CE certification procedure from other types of animal graft.
The certification procedure requires the consent and validation of the processes by all the Higher Health Institutes of the European Community to allow the free circulation of the material.
The checks require the following steps:
Analysis of the origin of the raw material and traceability of the product by the Notified Body
Annual inspection by the Notified Body of the sampling station
Verification of the absence of cross-contamination in the production phase
Verification and validation by the Higher Health Institutes of the deactivation and inactivation processes of prion charges.
Verification of Quality Systems
Approval by all European Ministries of Health to issue the CE certification
The biological functioning
The EXAFLEX membrane is made up of a double layer of multidirectional braided collagen fiber. It therefore has an extremely compact non-stick side and extremely resistant to the passage of bacteria and a fibrillar side which constitutes an ideal environment for cell revitalization.
The bilayer membranes undergo a revitalization by the endogenous connective tissue in 3 stages:
Fibrocytes migrate into the fibrillar layer and contribute to its anchoring to the surrounding structures by forming a neo membrane surrounding the implant.
The fibrocytes migrated into the three-dimensional structure of the bilayer membrane initially do not synthesize collagen but adapt their metabolism to contribute to the maintenance of existing collagen fibers.
After a few months the degradation of the three-dimensional structure induced by collagenase begins. Collagen is broken down and replaced by new fibrocytes. The neostructure is infiltrated and nourished by capillaries that grow easily in the three-dimensional matrix.