BIOSHIELD POCKET YOUR FLEXIBLE SOLUTION

Biological Membranes for Plastic & Reconstructive Surgery

Designed for Reconstructive Plastic Surgery, the Exashape membrane is processed through a proprietary method that maintains the unique qualities of natural bovine pericardium¹.

Exashape Bioshield pocket guarantees fast integration times with cell ingrowth², minimal inflammation³ and negligible serum production, while maintaining remarkable mechanical properties¹.

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OUR SECRET IS BILAYER.

The two layers perform a specific task in the integration process.

Fibrous layer: highly porous, it welcomes cells and, together with the matrix components, allows cytokines and growth factors to trigger the immediate revitalization process and early neoangiogenesis [2].

Compact layer: it is quickly repopulated by fibroblasts and VEGF². After implantation, there is no accumulation of inflammatory or giant cells. It is the part that provides the most solid structural support.

THREE-STEP INTEGRATION

The bilayer membrane undergoes a 3-stage process of revitalization by endogenous connective tissue.

1

During implantation, the collagen matrix absorbs the blood and the revitalization process begins immediately, characterized by a controlled and short-lived inflammation phase with considerable neoformation of vessels [2,3].

2

Fibroblasts reactivate collagen by triggering the ingrowth of new vessels, which provide the metabolic needs. At this stage of the reparative process, cell proliferation prevails, which targets the growth of new tissue [2].

3

The actual remodeling phase begins its course and is the result of the precise balance in the synthesis of collagen, which becomes an integral part of the tissue [3].

PRO-HEAL…BY NATURE

The cell-friendly process preserves the active elements in the repair process within the membrane: proteoglycans, hyaluronic acid, fibronectin, elastin and of course, native collagen. They represent a natural reservoir of bioactive factors, which participate in the revitalization process by controlling inflammation while promoting cell proliferation and migration [2]. We limit the amount of biological mass implanted (up to 50% less, due to lower thickness of pericardium compared to dermis) promoting integration even in cases of poor blood supply, while maintaining the highest bio-mechanical performance [1,4].

WELCOME TO THE 3rd DIMENSION

PRE-SHAPED | READY IN 60″ | RAPIDLY INTEGRATED

PRE-SHAPED

The membrane’s shape is conceived for anatomical and round implants. A perfect support is achieved by tightening the petals so that wrinkle-free tailor-made protection for each implant profile or volume, without waving or wrinkling which, as with thick matrices, can be sometimes perceptible in thinner patients.

ULTRA-LIGHT

Less than 0.6 mm thick, this membrane helps to minimize the foreign body response by facilitating rapid integration and faster tissue regeneration. The overall biological mass is 50% less than other membranes dermal based.

MESHED

The meshed scaffold design optimizes fluid drainage preventing accumulation. The perfect balance in the proportion between cut-outs and collagen best support timing of regeneration.

SELECTED SHIELD

Bioshield pocket 3D adapts more effectively to the implant and it shields only where needed: the dermal flap interface. This way foreign body reaction is minimaized, and also healing process is not overloaded with unnecessary effort to remodeling exceeding biomass.

FAST, TOUCHLESS ASSEMBLY

The new pre-shape design facilitates a rapid, touchless assembly procedure that can be completed in less than 1 minute minimizing the risk of contamination and ensuring a sterile environment far optimal surgical outcomes.

PRODUCT INFO

PREPECTORAL

Bioshield POCKET 3D

SIZES AND REFERENCES

(W x H x Proj.)

CodeModelSize
AEPB(F)154-158H050SIZE A15,5 x 15 x 5 cm​
AEPB(F)174-178H055​SIZE B17,5 x 17 x 5,5 cm​
AEPB(F)194-198H065SIZE C19,5 x 19 x 6,5 cm​

BIOSHIELD POCKET

A patented design mesh that improves surgical procedures.
Bioshield Pocket® serving as an elective option for immediate PrePectoral breast reconstruction for the protection of the implant/tissue interface

Bioshield Pocket® aims to streamline surgical procedure as the rehydrated membrane allows for quick wrapping of the implant without the need for complex tailoring procedures, reducing intra-operative delays, lowering risks of implant damage and potential contamination

After running the threads through the “petal” holes, the mesh is rehydrated in the sterile tray, with the smooth side facing the operator. Subsequently, the anterior surface of the implant is positioned on the membrane within a few seconds. The ‘petals’ are tightened to the implant’s posterior side creating a “purse string” assembly.

Due to the meshed pattern and rough external surface, Bioshield Pocket® offers a secure grip on the chest wall ensuring that the implant remains in place during and after surgery.

The high drapability allows the membrane to follow the silicone implant shape with no “dead spaces” or wrinkles

PRODUCT INFO

PREPECTORAL

Bioshield POCKET

SIZES AND REFERENCES

(W x H x TH)

CodeModelSize
AEPB(F)144-188S​SMALL18 x 14 cm x 0,5 mm​
AEPB(F)164-208S​MEDIUM20 x 16 cm x 0,5 mm​
AEPB(F)184-228S​LARGE22 x 18 cm x 0,5 mm​
AEPB(F)204-238SEXTRA LARGE23 x 20 cm x 0,5 mm​

ALSO AVAILABLE IN KIT

Including 2 X resorbable monofilament PGCL sutures for the preparation of the “purse string” assembly

CodeModelSize
POCKET S 4.0KIT SMALL18 x 14 cm x 0,5 mm​
POCKET M 4.0KIT MEDIUM20 x 16 cm x 0,5 mm​
POCKET L 4.0KIT LARGE22 x 18 cm x 0,5 mm​
POCKET XL 4.0KIT EXTRA LARGE23 x 20 cm x 0,5 mm​

PREPEC

Exashape Prepec

Exashape Prepec is a rectangular meshed membrane. Thanks to its expansion ratio, after rapid rehydration it is able to cover implants of all shapes and sizes, with minimum handling and maximum stretchability/drapability

PRODUCT INFO

PREPECTORAL

Exashape PREPEC


SIZES AND REFERENCES

(Wx H x TH)

CodeModelSize
AEPB(F)058-100S​Rectangular10 x 5 cm x 0,5 mm​
AEPB(F)058-200S​Rectangular20 x 16 cm x 0,5 mm​
AEPB(F)108-150S​Rectangular15 x 10 cm x 0,5 mm ​
AEPB(F)108-200S​Rectangular20 x 10 x cm x 0,5 mm​
AEPB(F)158-200S​Rectangular20 x 15 cm x 0,5 mm​
AEPB(F)158-150S​Squared15 x 15 cm x 0,5 mm​

GRID

exaShape Grid

exaShape Grid comes in 2 shapes:

3 x Half Moon
2 x Rectangular

They are both fenestrated with circular holes to optimize fluid drainage capacity. The membrane rehydrates quickly and is immediately available for use.

The range of sizes allows its immediate use in most patients

PRODUCT INFO

SUBPECTORAL

Exashape GRID


SIZES and REFERENCES

(W x H x TH)

CodeModelSize
AEPB(F)084-162S​Half Moon10 x 5 cm x 0,5 mm​
AEPB(F)074-172S​Half Moon20 x 5 cm x 0,5 mm​
AEPB(F)104-202S​Half Moon15 x 10 cm x 0,5 mm ​
AEPB(F)104-150S​Rectangular15 x 15 cm x 0,5 mm​
AEPB(F)104-200S​Rectangular20 x 15 cm x 0,5 mm​

EXPANDER

Exashape Expander

Exashape Expander is used in combination with a breast expander in breast reconstruction procedures as a means of pocket closure.

It is ‘circular-hole’ fenestrated to optimize drainage capacity of fluids

PRODUCT INFO

SUBPECTORAL

Exashape EXPANDER

SIZES and REFERENCES

(W x H x TH)

CodeModelSize
AEPB(F)064-080S​Rectangular8 x 6 cm x 0,5 mm​

NAC

Exashape NAC®

Exashape Nac® is a perforated membrane used in breast reconstruction procedures for the areola-nipple area in order to create supplementary tissue, to cover a nipple reconstruction device or for a stand-alone use. It is fenestrated with circular holes to optimise fluid drainage capacity

PRODUCT INFO

Exashape NAC

SIZES and REFERENCES

(W x H x TH)

CodeModelSize
AEPB(F)084-080S​Round8 x 8 cm x 0,5 mm​

BIOSHIELD POCKET PRO

PROTECTION OF
UPPER QUADRANTS

PROTECTION OF
LOWER QUADRANTS

IN CONJUNCTION WITH
BIOSHIELD POCKET

Bioshield PRo allows different usage options, such as selective coverage of the upper or lower quadrants of a silicone breast implant.

In addition, it can be used for wrapping a breast implant in combination with the Bioshield Pocket® membrane to achieve greater coverage, increasing containment capacity, and allowing the coverage of larger implants

PRODUCT INFO

Bioshield POCKET Pro

SIZES and REFERENCES

(W x H x TH)

CodeModelSize
AEPB(F)080-099S​SIZE A8 x 9 cm x 0,5 mm​
AEPB(F)100-119S​SIZE B10 x 11 cm x 0,5 mm​
AEPB(F)120-139S​SIZE C12 x 13 cm x 0,5 mm ​
AEPB(F)140-159S​SIZE D14 x 15 cm x 0,5 mm​
AEPB(F)160-179S​SIZE E16 x 17 cm x 0,5 mm​

REFERENCES

  1. Bielli, A., Bernardini, R.,et al. (2018) Characterization of a new decellularized bovine pericardial biological mesh: Structural and mechanical properties. Journal of the Mechanical Behavior of Biomedical Materials. 78 (2018) 420–426
  2. Bernardini, R., Varvaras D., D’Amico F., et al. (2019) Biological acellular pericardial mesh regulated tissue integration and
    remodeling in a rat model of breast prosthetic implantation. J Biomed Mater Res. 2019;1–14
  3. Varvaras, D., et al. (2017) Safety, tolerability, and efficacy evaluation of immediate total wrapping with biological mesh
    implant-based breast reconstruction: an under-estimated subcutaneous approach with “biological texturization”
    prostheses. Preclinical animal study. The Gulf Journal of Oncology, Supplement January 2017
  4. Capuano, I., Bernardini, R., Varvaras, D., Mattei, M. (2020) Acellular Dermal Matrix in Prosthetic Breast Reconstructive
    Surgery with Prepectoral Technique: A Literature Review. Journal of Experimental Pathology. Volume 1, Issue 2: 50-59
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