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Bioshield Pocket™

Bioshield Pocket™

Natural strength and rapid integration with sutureless placement.

An extracellular matrix with superior strength2 that provides a natural anchoring effect, removing the requirement to suture in place.  The ultra-thin, meshed matrix is gently purified to maintain the natural ‘pro-heal’ properties in the bi-layer bovine pericardium. All of these qualities combined provide the ultimate solution for consistently reliable results. 

Bioshield Pocket™ is designed to reduce complications and provide optimal patient outcomes in pre-pectoral breast reconstruction:

Quick – rapid hydration and anterior coverage of the implant in minutes, without the need for time-consuming adaptation.

Bioshield grip – the natural presence of a high friction, fibrous exterior provides a natural anchoring effect, avoiding the requirement for suturing the construct to the chest wall in most cases. Whilst also being an ideal environment for cell revitalisation, leading to rapid cell integration.     

Rapid integration2 – non-crosslinked purification process preserves ‘pro-heal’ elements which promote cell proliferation and migration. The volume of biological mass present is also up to 50% less than alternatives, further promoting the speed of cell ingrowth.

Superior strength1 – a naturally strong raw material that enhances the Surgeon’s control of the implant within the mastectomy pocket and provides consistent aesthetic results, whilst also enabling easy handling and positioning of the matrix around the implant.

Microscopic side view of Bioshield Pocket Matrix
Microscopic side view of Bioshield Pocket Matrix

High-Performance Bovine Pericardium

Bioshield Pocket™ is an extracellular dermal matrix sourced from bovine pericardium, which is known for its low immunogenicity. The matrix is processed through a patented method that maintains the unique strength and bi-layer qualities of natural pericardium1. These unique qualities perform specific tasks in the integration process:

Fibrous exterior surface: This highly porous surface is ideal for cell revitalisation. It welcomes cells and, together with the preserved active ‘pro-heal’ elements, allow cytokines and growth factors to trigger the immediate revitalisation process and early neoangiogenesis2.

The fibrous surface is placed in contact with the skin flap. The natural properties of the pericardium provide the anchoring and protection of the matrix due to the fibrous connective structures (fibrocytes).

Compact smooth layer: The prothesis facing surface is compact and resistant to bacteria. It hosts a natural reservoir of bioactive factors which avoid inflammatory reaction and promote cell proliferation for quick repopulation of fibroblasts and VEGF2.

 

Expertly engineered design

Bioshield Pocket™ is manufactured in Italy and has been designed by a team of experts in consultation with leading and world-renowned surgeons. This extensive knowledge has led to the engineering of an innovative advance in biological matrixes for breast reconstruction, prioritising the following areas:

Innovative design: the petal design of the Bioshield Pocket™ is perfectly engineered to maintain a low profile and uniform wrapping technique, avoiding excess biological mass. The meshed design allows for increased elasticity and placement whilst primarily assisting in fluid drainage and vascular ingrowth.

Strength: the pericardium origin provides reliable strength for handling and placement around the matrix, enhancing aesthetic outcomes, as well as positioning and control over the mastectomy pocket leading to better cosmesis and reductions in ptosis.

Bioshield grip: the engineers specifically adapted the patented decellularisation process to ensure that the natural properties of the pericardium are maintained. This provides a fibrous exterior enabling an anchoring effect with the pocket.   

Low volume of biological mass: the natural strength of the raw material allows for an ultra-thin profile of just 0.5mm resulting in a significant reduction in implanted biological mass (up to 50% less*)

Ease of handling: rapid hydration with a stable matrix structure that allows for easy handling and placement.

Reduced operating time

Preparation: Bioshield Pocket™ rapidly hydrates  and the simple purse-string closure of the innovative design allows anterior coverage of the implant in minutes. The hydration tray and sutures are provided with the matrix for easy assembly.

Placement: The secure and precise placement of the matrix to the implant is quick and simple, without the need for time-consuming adaptation.

Positioning: Reduced requirement to suture in place due to the unique gripping properties of the bilayer bovine pericardium.

Pro-heal elements

The patented cell-friendly purification process preserves the active elements in the natural material which assist in the natural repair process, namely proteoglycans, hyaluronic acid, fibronectin, elastin and native collagen.

These elements represent a natural reservoir of bioactive factors which participate in the revitalisation process by controlling inflammation whilst promoting cell proliferation and migration2.

The presence of these pro-heal elements leads to minimal inflammation3 and negligible serum production, while maintaining the remarkable mechanical properties of the pericardium for the highest bio-mechanical performance1.

 

 

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
*Compared to dermal based devices where the matrix is >0.9mm.

The Bioshield Pocket™ is available to accomodate virtually all sizes and models of breast implants on the market. The width and length ratio, along with the pattern of incisions on the matrix, enable perfect anterior coverage for implants up to 650cc.

 BOX / KIT CODE

BIOSHIELD POCKET PRODUCT CODE

BIOSHIELD POCKET SIZE
POCKET S AEPB(F)140-188S 18 x 14 cm
POCKET M AEPB(F)160-208S 20 x 16 cm
POCKET L AEPB(F)180-228S 22 x 18 cm
POCKET XL AEPB(F)200-238S 23 x 20 cm

Completing the ExaShape* portfolio, we also have matrices sized specifically for use in sub-pec placement:

PRODUCT CODE

PRODUCT DESCRIPTION

SIZE
AEPB(F)108-200S Rectangular Meshed 10 x 20 cm
AEPB(F)084-162S Half moon perforated 8 x 16 cm
AEPB(F)074-172S Half moon perforated 7 x 17 cm
AEPB(F)104-150S Rectangular perforated 10 x 15 cm
AEPB(F)064-080S Rectangular perforated 6 x 8 cm

 

*ExaShape is a family of highly engineered bilayer bovine pericardium membranes. ExaShape is the parent name for the range to which Bioshield Pocket belongs. All matrices in the ExaShape family are derived from processing the pericardium from cattle, under 24 months of age, selected and controlled at all stages of growth for feed and the environment in which they grow.

Company

REGEN MEDICAL Ltd
Unit 11 Interface Business Park
Bincknoll Lane
Royal Wootton Bassett
Wiltshire
SN4 8SY

Part of the Joint Operations family

Company no. 11180724
VAT no. GB 329567956

Contact

OFFICE HOURS:

Mon - Fri 08:30 to 17:30
Tel. 01793 575 050

Email: 
customerservice@regenmedical.co.uk

OUT OF HOURS BURNS SUPPORT:

Tel. 01793 575 041

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