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Egis ADM

Egis ADM


Egis ADM



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  • Productinformatie


EGIS® is designed by DECOmed s.r.l.

Regenerative Force
Muscle fascia repair with surgery can substantially be obtained in two ways: by applying inert reinforcement mesh or stimulating the body’s regenerative strength with biological prosthesis.

Innovation and Myth
The term EGIS® comes from the Greek aigis and identifies the indestructible skin which covered Zeus’ shield, fashioned by Hephaestus.
EGIS® is a highly valuable protective membrane and is currently the result of the most advanced research in the biotechnology field.

Regenerative surgery
REPAIR OF THE MUSCLE FASCIA with biological prostheses that are not artificially altered (not cross-linked) is based on biological processes which lead to the reconstruction of the missing fascia with tissue newly formed by the body itself. The mechanisms which the organism uses to regenerate the sca!olds of natural biomaterial have been known for only a few decades:
- Inflammation: the body’s initial reaction to the implant.
- Regeneration: healing phase. Granulation tissue formation.
- Remodelling: replacement of the biological prosthesis
with new connective tissue.

Reparative surgery
THE REPAIR OF THE MUSCLE FASCIA with synthetic or
cross-linked patches is based on the concepts of physical
and mechanical resistance, but from a biological
viewpoint no tissue generation phase is included.
Synthetic patches and artificially modified biological
patches (cross-linked) induce defence reactions in the
body. A"er an initial inflammatory phase, these inert
materials steer the organism’s healing process towards
encapsulation of the implant. 1,2,3






Reparative surgery benefits from the properties of the biomaterials ability to reproduce a certain function from a physical and
mechanical viewpoint; however, regenerative surgery is based on the ability of active biomaterials to transform themselves into
autologous tissue with anatomical-functional recovery.

Clinical outcome and anatomical-functional recovery
The choice of biomaterial has proven to be crucial for guiding tissue healing processes not just towards a positive clinical outcome, but also towards an anatomical-functional recovery.
EGIS® is a natural non-cross-linked matrix composed exclusively of porcine derived collagen (ADM-Acellular Dermal Matrix) which is fundamentally the same as human collagen. Thanks to its bioavailability it is recognized by the body as if it were part of it. It acts as an active sca!old in the granulation phase guiding healing towards long term clinical success (anatomical-functional recovery).

Natural matrix, mechanical properties
Recent studies have demonstrated that early complications a"er biological matrix implant may depend on imperfect decellularisation of the matrix, and on the presence of cross-linked substances or preservatives. 4,5,6
The exclusive production process which EGIS® undergoes was developed in order to guarantee a completely natural product, not cross-linked, and without the presence of any chemicals which can amplify the inflammatory phenomenon and slow down the regular progression of tissue regeneration.
The native protein structure gives EGIS® excellent mechanical properties able to fully withstand intra-abdominal pressure.

To guarantee the characteristics of EGIS® over time, the final phase of the production process includes freeze-drying to remove all liquids using exact pressure and temperature values.
This process makes the final product dry, excellent for correct storage at room temperature and which only requires simple rehydration before the implantation.


The histology demonstrates the remodelling process performed on the EGIS® porcine
dermal implant. In the upper part infiltration by the fibroblastic cells and rich
neovascularisation can be observed.

Active natural matrix
Nowadays the concept of biocompatibility is not su!icient for securing the e!ectiveness of a biomaterial. Its performance must go beyond the threshold of passive tolerability. It must be active, not inert, in order to enhance the biological process of Guided Tissue Regeneration.7
EGIS® originated as a completely natural product. It is composed of collagen obtained from porcine dermis which is fundamentally the same as human collagen.
EGIS® maintains the original structure and excellent mechanical resistance of proteins without needing induced structural modifications (cross-linking) thus providing immediate bioavailability.

As a natural extracellular matrix EGIS® maintains the structure of the pre-existing microvascular network. This allows the patient’s blood to easily permeate the matrix accelerating cell migration and tissue regeneration.






Inert gra"s
The structural alteration (cross-linking) of a biological matrix may lengthen the remodelling time or completely stop it significantly limiting cell migration. From a biological viewpoint these artificially modified products behave similarly to synthetic meshes provoking a reaction in the body which results in encapsulation.

Indications
Protection and regeneration of so! tissues in thorax-abdominal sites
EGIS® maintains the original structure and excellent mechanical resistance of proteins without the need for chemical reinforcements (cross-linking) promoting tissue regeneration. Thoracic wall defects, which in the past were repaired with synthetic prostheses were not able to withstand infections, and are now widely treated with biological matrices. 8









Incisional hernia treatment
EGIS® is able to withstand pressures much higher than those exercised on the peritoneum, including when under strain. Its natural integrity means it can also be implanted in contact with the loops. The concept of using surgical mesh to repair hernias was introduced more than 50 years ago. Repair with biological prosthesis is now widely recognized as superior to repair with direct suturing or synthetic prostheses. 9








Prevention and treatment of parastomal hernia
The surgical treatment procedure for parastomal hernias is closing of the defect by direct suturing or reinforcement with prosthesis. The prophylactic use of surgical mesh to close the defect at the time of the stoma’s creation is now widespread to prevent the onset of new hernias. The synthetic mesh implant in these indications is not recommended due to the high risk of skin erosion and fistula formation. 10








In association with VAC therapy
When the defect is too extensive for a primary closing of the walls, VAC therapy is performed to allow healing of the wound by secondary intention by applying negative pressure to the site. EGIS® is indicated in association with this therapy, before the wound bed is ready for a skin gra" which completes the closing. 11









Laparoscopic surgery
EGIS® is also available in 0.8 mm thickness. Its so"ness and malleability makes it easy to use in laparoscopic operations. EGIS® does not encounter any difficulties passing through a trocar and can be easily sutured with metallic or reabsorbable staples using common staplers.









References


Bibliography
1 Liang HC, Chang Y, Hsu CK, Lee MH, Sung HW. E!ects of Crosslinking degree of an acellular biological tissue on its tissue regeneration pattern.
Biomaterials. 2004
2 Butler CE, Burns NK, Campbell KT, Mathur AB, Ja!ari MV, Rios CN. Comparison of cross-linked and non-cross-linked porcine acellular dermal
matrices for ventral hernia repair. Journal of the American College of Surgeons, 2010.
3 Corey R. Deeken, Lora Melman, Eric D. Jenkins, Suellen C. Greco, Margaret M. Frisella, Brent D. Matthews; Histologic and Biomechanical
Evaluation of Crosslinked and Non-Crosslinked Biologic Meshes in a Porcine Model of Ventral Incisional Hernia Repair. Journal of the American
College of Surgeons, 2011.
4 Maryellen Sandor, Hui Xu, Jerome Connor, Jared Lombardi, John R. Harper, Ronald P. Silverman, and David J. McQuillan; Host Response to
Implanted Porcine-Derived Biologic Materials in a Primate Model of Abdominal Wall Repair. Tissue Engineering Part A, 2008.
5 James M. Anderson, Analiz Rodriguez, David T. Chang; FOREIGN BODY REACTION TO BIOMATERIALS. Semin Immunol. 2008
6 Badylak SF, Gilbert TW; Immune response to biologic sca!old materials. Semin Immunol, 2009.
7Cornwell KG, Landsman A, James KS.; Extracellular matrix biomaterials for so" tissue repair. Clin Podiatr Med Surg. 2009
8 Phillip S. Ge, Taryne A. Imai, Armen Aboulian, Timothy L. Van Natta. The Use of Human Acellular Dermal Matrix for Chest Wall Reconstruction.
The Annals of Thoracic Surgery, 2010.
9 CN BROWN, JG FINCH. Which mesh for hernia repair? Ann R Coll Surg Engl, 2010.
10 Nicholas Jonathan Slater, Bibi M. E. Hansson, Otmar R. Buyne, Thijs Hendriks, Robert P. Bleichrodt. Repair of Parastomal Hernias with
Biologic Gra"s: A Systematic Review. J Gastrointest Surg, 2011.
11 B. G. Scott, M. A. Feanny, A. Hirshberg. EARLY DEFINITIVE CLOSURE OF THE OPEN ABDOMEN: A QUIET REVOLUTION. Scandinavian Journal
of Surgery 2005.