biodynamictissue

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distributor
Via delle Industrie 2/4 - 30020 Marcon (VE) Italy
tel. +39 041 5020370 - fax +39 041 5020366
[email protected] - www.protexa.it
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Tecnoss, an Italian company
with a site in Turin
is a leader in the tissue
bioengineering sector.
Thanks to its patents (ECPT)
it has been deantigenizing
heterologous matrixes for 15 years,
and distributing its biomaterials in
40 countries around the world.
350,000 implants to date.
DECOmed, an Italian company
with a site in Venice
has been present in the
medical-surgical market
since 1989.
Distributing specialist
and high technology products
throughout Europe.
Tecnoss and DECOmed present Protexa,
an Italian project set up in 2008
and developed in collaboration with surgical specialists:
supplying safe, high technology products
at an accessible price.
Protexa. Made in Italy.
www.protexa.it
[email protected]
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Your Mastery...
The ‘direct’ repair of the ventral hernia is hindered by the high percentage of recurrences
due to the tension exercised on the fascia of the suture and to the conditions of the tissue
tropism.
Since the first half of the 900’s the most diverse and inert materials
have been researched for use in the closure of a wound or incision without placing tension on the fascia. Only in the second half of the 900’s
was polypropylene used, having been shown to be the most fit for this
purpose. There are also meshes in polypropylene adapted for coming
into contact with the bowel loops, and in polyester coated with absorbable substances which facilitate the rehypertonization, some coated in
silicone, others in PTFE.
The problem with this type of prosthesis is the fact that, although inert,
it is a foreign body and these can bring complications such as infection,
fistulization and erosion of the skin.
There are some predisposing conditions to infection which put the successful outcome of the implantation at risk.
In order to prevent this, it is imperative to be able to trust in a mate-
Is it possible
a more enlarged
indication?
rial which gives us the same guarantee as a
synthetic prosthesis (resistance to tension, malleability, biocompatibility, allergy resistance),
but doesn’t behave as foreign body. Biological
prostheses is a category which incorporates all
of these characteristics, but at the same time
guarantees better protection against infection.
which is fixed around the circumference of a
wound or incision with re-absorbable stitches
so as to keep it in position. The biological
prosthesis offers the guarantee that once implanted, it becomes a structure recognized by
the organism. It becomes revascularized and
reinforces the deficit in the fibrotic structure.
The site of the positioning of the organic prosthesis is similar to that of a synthetic mesh,
The application of this material is therefore
used electively in all cases where there is po-
tential contamination of the wound (the presence of a colostomy, tearing of the intestine, a
history of infection of the site)
Should the producers of the product render
it more accessible in terms of cost, it would
be available for more widespread use also in
patients at risk from potential infection due to
comorbidity (immunodeficiency, advanced age,
nutritional state, diabetes, obesity, corticosteroid therapy etc.)
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...our background
For 15 years the Tecnoss laboratory of Turin
has been deantigenizing under its own
heterologous matrix patent.
In forty countries all over the world, surgical specialists use Tecnoss biomaterials. To date, more than three hundred and fifty thousand implants.
This expansion in the market has effectively absorbed the cost of the research, and today, has allowed the extension of the use of a biological
prosthesis which meets economical needs along with the need for more advanced surgical performance.
FAQ
Q: Can the biological prosthesis be reabsorbed, allowing the hernia to reform?
A: No. The prosthesis constitutes a support
which re-enforces the abdominal wall,
being recognized, revascularized and becoming a substitute for the missing tissue.
Q: Can the prosthesis be rejected?
A: No. The prosthetic material is properly
treated (deanitgenized). It is a natural constituent of the organism, and in this way is
perfectly biocompatible.
Q: Can the prosthesis be encapsulated as a
foreign body?
A: No. Being completely biocompatible, it becomes revascularized and entirely accepted. For this reason even its macroscopic
recognition can be difficult in the case of
revision.
Q: Can the prosthesis be used for when performing Miles’operation?
A: Yes. Since it acts as a filler, it can be used
both for closure after the pelvic exploration
in laparoscopy, and open surgeries. It can
also be used to reinforce the posterior band
of the ano praeter.
Q: Are there clinical indications for using the
biological prosthesis during the Nissen
fundoplication for hiatus hernia?
A: Yes. The organic prosthesis is perfectly
adapted for reinforcing the proximity of
the diaphragmatic pillars, also in the case
of revision, or to bridge the gap should the
pillars be too far apart.
Q: Can the prosthesis be used for, and how do
they function in pelvic floor reconstruction
surgery?
A:They can assuredly be used and give more
security in cases at risk of infection due to
the accidental opening of the colon and/or
vagina.
Q: Can the biological prosthesis be used in
cases in which there is the presence of
macerated skin, problems of regeneration
of the tissues, proximity of the stomy?
A: Yes. The biological prosthesis provide the
best guarantee against risk of infection,
and it is therefore possible to use it also
in the presence of colostomy (parastomal
hernia) in patients with ascites, macerated
skin and dystrophic tissue.
Q: Is it possible to use the prosthesis for immunodepressed patients?
A: Yes. Ventral hernias in transplant patients
are relatively common, and the dilemma of
choosing whether or not to use prosthetic
materials which may be the cause of infection, is resolved by using a biological prosthesis.
Q: How does the biological prosthesis perform
when used with Trocar?
A: It performs excellently. It is easy to roll and
insert into the trocar, and likewise as easy
to extract and extend.
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Guided tissue regeneration
The structural integrity
of the extracellular matrix:
A key factor in its clinical success
These characteristics of the Tecnoss manufacturing process more
than adhere to the safety requirements; a substantial cellular and
vascular colonization of Protexa, for close contact
and a gradual remodeling of the endogenous neo-tissue. In fact, it is
the collagen preserved in the integrated extracellular matrix which
has a fundamental role in the tissue regeneration, as:
a) It acts as a sound substrate for platelet activation and aggregation;
b) It is able to attract and stimulate the differentiation of mesenchymal
stem cells in the bone marrow;
c) It increases the levels of proliferation of fibreblasts by 2/3 times ;
d) Contact with it promotes the aggregation and subsequent platelet
lysis, which is the very first stage of tissue healing.
1)Salasznyk RM, et al. Journal of Biomedicine and Biotechnology (2004),
1:24-34
2) Hsu FY, et al. Biomaterials (1999), 20: 1931-1936
The identification of the
sequence of events which
bring about guided tissue
regeneration has allowed us
to indentify the key factors
in the process of guiding; the
simultaneous presence of three
fundamental components is the
prerequisite for the ‘de novo’
formation of tissue.
–The platelets are the key players during the first phase of the healing process,
when, following a lesion, initially a fibrin
deposit and the formation of blood clots
take place; This stage is characterized by
significant activation of the chemical signs
mediated by cytokines and growth factors.
In fact, the primary post haemorrhagic clot
formation process through platelet aggregation and lysis, determines the release of
both the coagulation cascade factors and
of the growth factors including PDGF,
I’IGF1, I’IGF2, AND VEGF, which are known
for their activating effects on fibroblasts.
–The fibroblastic precursors are derived
from mesenchymal bone marrow stem
cells, once they are differentiated fibroblasts through collagen synthesis and other
components of the extracellular matrix,
they become responsible for the second
phase of the guidance process.
– An insoluble substrate, which acts as a
suitable foundation to the process of tissue
regeneration, and carries out the support
functions and guidance of the formation
of new tissue. For example an integrated
extracellular matrix.
The continued progress in the comprehension of biological mechanisms which
regulate morphogenesis of the tissue can
also be capitalized on. They can aid the
development and expansion of both natural and artificial products able to restore or
maintain the function of damaged tissues
and organs (tissue engineering) 1, 2, 3
1) Griffith LG, Naughton G. Science (2002); 295:
1009-14
2) Reddi AH. Tissue Eng (2000); 6: 351-59
3) Nakashima N, Reddi AH. Nature Biotechnology
(2003); 9: 1025-32
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The Product
Characteristics: a Collagen membrane obtained from porcine dermis, using the exclusive
process of Enzymatic-Chemical-Physical Treatment at Low Temperature (ECPTLT). Its consistency and resistance allow perfect stabilization, as well as prolonged protection of the
receiving site after draining and suturing the surgical flaps.
Clinical Indication. A matrix of biological tissue to repair, support and
regenerate sections of lost tissue, either as membrane protection, or as
partial or full reconstruction and recovery of the sections of tissue lost.
Packaging. Double packaged in sterile, single use form.
Sterilization. Product sterilized by gamma ray.
Warning. The product has not been tested on pregnant patients.
Safely from nature to man
Tecnoss develops and manufactures animal-derived biomaterials from which they originate
new concept medical devices intended to provide valuable and innovative aids which assist
the surgeon and give clinical benefits to the patient.
A special technology is used in the preparation of the materials. This
technologyenables the neutralization of antigenic products present
in animal tissue (achieving biocompatibility), allowing you to obtain
unique products which meet every surgical need.
Thanks to Tecnoss’ biomaterials it is possible to obtain excellent results
in healing, characterized by active colonization of the recipient site by
the cells of the patient in order to facilitate the process of fully recovered injured tissue.
The raw materials which Tecnoss uses in its products derive from Italian
raised animals, selected and certified under the control of the Servizio
Sanitario Nazionale Veterinario (The national veterinary sanitation
service). Tecnoss biomaterials conform to the production regulations
of the European Directive 93/42/CEE (D.Lgs 47/97 and Modified Directive 2007/47/CEE), 2003/32/CE (D.Lgs 67/2005). The Istituto Superiore di Sanità (The Higher Institute of Health) is the notified body
(0373) for the CE mark of Tecnoss’ medical devices. The organic matrix
from which Tecnoss’ line of medical devices is derived is subject to ISO
10993, which is a series of biological and histocompatibility tests from
which the complete and perfect bioavailability and biocompatibility of
the products have emerged.
Instructions for use. Open the packaging and immerse the membrane in a tepid, sterile saline solution for 15-20 minutes. After
adapting the membrane to the required shape and size using sterile instruments, position it onto the receiving site, and proceed
with the suture of the surrounding tissue.
Should the product be exposed, its removal is recommended only
in the presence of an evident superinfection, as the size and nature of the product allow healing of the wound by secondary intention.
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Histological
Examination
Protexa
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Protexa
Samples of deantigenized
porcine collagen
prosthesis using the
Tecnoss method.
The histological preparations were set up
using an uncontaminated sample of Tecnoss
Dermis (Protexa) hydrated according to the
instructions for use on patients, subjected to
brief fixation (1 hour) in formalin, processed
according to standard procedures and stained
in hematoxylin-eosin.
n
A sample of tissue taken six
months after implantation,
during unrelated surgery.
The fibrous-connective tissue of the patient
and porcine collagen membrane obtained by
the Tecnoss method can be recognized. There
is a complete absence of inflammatory reaction on the interface between the prosthesis
and autologous tissue.
AUTOLOGOUS TISSUE
AUTOLOGOUS TISSUE
The histological examination demonstrates
that the prosthesis consists solely of collagen
fibres without cellular elements.
The colonization of the prosthetic membrane
by newly formed tissue can be seen, exhibited by the presence of newly formed vessels
or fibroblastic cells, highlighted by vimentin,
between the collagen fibres of the membrane
protex. The lack of inflammatory reaction, demonstrated by the presence of few lymphocytes
can be appreciated.
Immunohistochemical investigations demonstrated a negative result both for vimentin and
CD31.
Vimentin: is one of the five cytoplasmic intermediate filaments (MW 57,000).
and present in mesenchymal cells such as fibroblasts, endothelial cells and smooth muscle cells.
By kind permission of Prof. A. Iannucci Verona, Italy
Protexa
Protexa
By kind permission of Prof. A. Iannucci Verona, Italy
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Clinical Indications
which was accentuated during straining. It
was decided to repair the area of weakness
using biological prosthetic material (Protexa)
as closing first was not feasible and the use
of another type of synthetic graft was considered, given the anatomical location, to be
putting the patient at high risk of infection.
Protexa
Patient underwent protective colostomy
performed during an operation for intestinal resection and reconstruction performed
in emergency for perforated diverticulum.
Some months later the patient developed a
significant ventral hernia. The surgical program was to restore the intestinal continuity,
close the ostomy, and to concurrently conduct
a massive incisional hernia repair. Given the
possibility of infection with a synthetic graft,
the use of a biological prosthesis (Protexa)
was decided upon.
By kind permission
of Doctor U. Tedeschi. Verona, Italy
Protexa
Patient underwent amputation of the coccyx
due to painful subluxation following a fall. In
the area of the coccyx a symptomatic hernia
can be seen with herniation of the rectum,
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prosthesis (Protexa) was also used to bridge
the fascial defect.
By kind permission
of Doctor U. Tedeschi. Verona, Italy
Protexa
Patient operated on for anterior resection
due to rectal cancer in December 2006. During surgery was subjected to IntraOperative Radiation Therapy (IORT). The foreseen
post-operative radiotherapy was carried
out. The patient suffered an anastomotic
leakage with entero-cutaneous fistula. For
this reason a colostomy was given. Anastomotic dehiscence slowed the healing process, delaying recanalization. Meanwhile a
parastomal hernia and a middle incisional
hernia developed. The surgical program was
to restore the intestinal continuity, closing
the stoma, and to concurrently repair the
massive hernia. Given the possible infection
of any synthetic graft, the use of the biological prosthesis was decided upon. It was
decided to first repair the hernia, excluding
the site of the stoma and subsequently recanalize the patient. A piece of biological
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Certification and references
By kind permission
of Doctor U. Tedeschi. Verona, Italy
Protexa
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Male patient suffering from Crohn’s disease
had previously been given a sigma resection in 1997, accessed via right pararectal,
and right hemicolectomy and ileal resection
in 2004, via Xiphopubic midline incision.
The patient came under observation for a
terminal stenosis due to ileal segment and
a fistula enterocutanea. During intervening
periods had undergone surgery and medical
therapies (anticancer drugs, steroids, immunosuppressants and monoclonal antibodies).
It should be noted that following the two
surgical operations the patient had a xiphoumbilical hernia with atrophy of the right
rectus abdominis by denervation. The patient
underwent surgery due to vascular insufficiency consisting of resection of the stenotic tract and ileal tract and of the remaining
transverse colon via middle xipho- pubic approach. For abdominal restraint a biological
prosthesis (Protex) was opted for due to the
high risk of infection.
By kind permission
of Doctor R. Merenda. Mestre (VE), Italy
Product code
Product description
Sizes
Quantities
ED10PS
porcine dermis
10 cm x 10 cm x 1,4 mm
1 piece per package
ED07PS
porcine dermis
14 cm x 8 cm x 1,4 mm
1 piece per package
ED20PS
porcine dermis
20 cm x 10 cm x 1,4 mm
1 piece per package
ED24PS
porcine dermis
25 cm x 18 cm x 1,4 mm
1 piece per package
ED32PS
porcine dermis
30 cm x 20 cm x 1,4 mm
1 piece per package
www.protexa.it
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ED10 PS
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ED07 PS
ED24 PS
distributor
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ED20 PS
Via delle Industrie 2/4 - 30020 Marcon (VE) Italy
tel. +39 041 5020370 - fax +39 041 5020366
[email protected] - www.protexa.it
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