Bi-Layer Matrix

The choice for aesthetic and functional results in loss of substances

Skin Expertise with a new collagen technology

I.

II.

III.

IV. NEVELIA® dermal regeneration process

V.

VI. NEVELIA® Bi-Layer Matrix Clinical benefits for specific indications

VII.

I

NEVELIA® structure

NEVELIA® is a three-dimensional porous matrix of stabilized bovine origin type I Collagen.

NEVELIA® is made of a specific native collagen with a large fibrous proportion to keep cell adhesion signals and mechanical structure to support regeneration.

In vitro tests demonstrate an optimized colonization as fibroblasts recognize collagen fibers.

NEVELIA®

Colonization in the matrix thickness, many cells, strong collagen neosynthesis

OTHER BI-LAYER MATRIX

Colonization mainly on the surface, few cells, poor collagen neosynthesis

Additional NEVELIA® features are :

Optimized pore size3 (average pore size 100 μm) and open-cell structure promoting nutrients flow and fibroblasts migration

NEVELIA® MATRIX SEM photography

OTHER BI-LAYER MATRIX SEM photography

Crosslinking rate for a balanced absorption / regeneration process
No GAG added to keep cells attachment potential

NEVELIA® is composed of medical-grade silicone elastomer reinforced with a polyester material.

NEVELIA®

Reinforced silicone sheeting

OTHER BI-LAYER MATRIX

Non-Reinforced silicone sheeting

II

NEVELIA® utilizations

NEVELIA® is used for dermal regeneration in skin loss, especially in:

Burns surgery (third and deep second degree burns and burns sequelae)
Chronic wounds surgery (including leg ulcers and diabetic foot)
Traumatology
Skin tumors surgery
Reconstructive plastic surgery

NEVELIA® can also be used in children.

NEVELIA® is used in combination with a thin split thickness skin graft to recreate skin close to normal skin in terms of function and appearance.

III

NEVELIA®, an alternative to

Skin Expansion (Single or sequential)
Flaps (Local, distant, free …)
Split-Thickness or Full-Thickness skin autograft
Dermal graft (Allografts, Xenografts…)

IV

NEVELIA® dermal regeneration process

Day 0

Contracted scar

The surgery can be scheduled as soon as the patient is stabilized.

Day 1

Excision of the wound

All the dead tissue on and around the graft zone must be removed. For the success of NEVELIA® Bi-layer Matrix, all necrotic and scar tissues must be excised down to the viable tissue.

Day 1

NEVELIA® BI-LAYER MATRIX APPLICATION

NEVELIA® Bi-Layer Matrix must be cut to fit the excised wound size exactly. The collagen matrix must be in direct contact with the excised wound. The matrix will be fixed in place with surgical staples or sutures.

Day 1 to 21

Neoderm formation

The collagen matrix is quickly colonized by the patient’s cells and is gradually replaced by an autologous neoderm.

Day 21+

REMOVAL OF THE SILICONE LAYER

When the neoderm is formed, the silicone layer is removed. The reconstructed dermis has a distinctive orange-yellow or light yellow colour and may present with slightly reddish areas, sign of a good revascularization.

Day 21+

HARVESTING OF THE GRAFT

A thin split thickness skin graft must be taken, if possible from an area similar in colour to the reconstructed area. It must be removed with dermatome and may be meshed.

Day 21+

THIN SPLIT THICKNESS SKIN GRAFT

The graft is placed on the neoderm and it is fixed with staples or suture.

Day 45+

REGENERATED SKIN

Epidermization. Complete healing of the wound.

V

NEVELIA® benefits

NEVELIA® provides immediate wound closure and promotes dermal regeneration.

Click on image to see the schema larger

VI

NEVELIA® Bi-Layer Matrix

clinical benefits for specific indications

Burns surgery

Waiting donor site availability for extended burns

Chronix Wounds Surgery Nevelia - Symatese Aesthetics

Chronic wounds surgery

Good trophicity especially necessary in areas of friction, pressure
Adapted to prolonged healing time

Traumatology

Good trophicity especially necessary in areas of friction, pressure
Adapted to prolonged healing time to combine other treatments

Skin Tumors Surgery

Wise choice awaiting anatomopathologist results
Facilitates monitoring of cancer recurrence
Ease of care for the elderly through faster mobilization

VII

Additional benefits

NEVELIA® Bi-Layer Matrixcan improve treatment in a number of situations.

Immediate availability
Efficiency of the surgical technique
Creation of a thicker protective tissue and reestablishment of the gliding plan in noble elements coverage like muscles, bones, tendons
Better functional and aesthetic results compared to common dermo-epidermal graft
No additional scars in traumatology (versus flaps)
Reduction risk sequelae of donor site
Does not prevent alternative treatments
Reduction of hypertrophic scars and keloids occurrence
Faster procedure which can be performed in ambulatory room for specific indications (hand, skin tumors)

Children : allows better adaptation of tissue to child growth (less tensions & flanges)

REFERENCE MCS0505
NEVELIA® Bi-Layer Matrix for dermal regeneration – 5x5 cm – 1 Unit

REFERENCE MCS1015
NEVELIA® Bi-Layer Matrix for dermal regeneration – 10x15 cm – 1 Unit

REFERENCE MCS1030
NEVELIA® Bi-Layer Matrix for dermal regeneration – 10x30 cm – 1 Unit

REFERENCE MCS2030
NEVELIA® Bi-Layer Matrix for dermal regeneration – 20x30 cm – 1 Unit

NEVELIA® Bi-Layer Matrix is CE Marked by the notified body LNE/G-MED n°0459 and a Class III Medical Device made by SYMATESE-ZI les Troques-Chaponost-France.

Availability of the device can be subject to local regulatory registration. Please refer to appropriate Instructions for Use for complete product information. This product does not contain latex.

Warning: Applicable laws restrict the sale of these devices by or on the order of a physician. NEVELIA® is a trademark of SYMATESE.

INDICATIONS

NEVELIA® is indicated for dermal regeneration in individuals with skin loss, particularly in the following fields :
– Burns surgery (third and deep second degree burns)
– Reconstructive plastic surgery
– Traumatology
– NEVELIA® is used in combination with a thin split thickness skin graft to recreate skin resembling normal skin in terms of function and appearance.

NEVELIA® Bi-Layer Matrix is particularly useful for :
– patients who are unable to supply sufficient donor skin for an autograft at the time of excision

– When the physiological condition of the patient does not allow the autograft

CONTRAINDICATIONS

NEVELIA® Bi-Layer Matrix must not be used in patients presenting with :
– clinical signs of wound infection
– an allergic predisposition or known allergy to bovine collagen or silicone

BIBLIOGRAPHY

Prospective evaluation of NEVELIA® in terms of safety and efficacy for third-degree burns treatment and reconstructive surgery in the University Hospital of Bordeaux: electronic poster presentation at the EWMA 2017 conference in Amsterdam.
Instructions for use MCSN01D (May 2013)
Yannas, I. V., E. Lee, et al. (1989). «Synthesis and characterization of a model extracellular matrix that induces partial regeneration of adult mammalian skin.» Proc Natl Acad Sci U S A 86(3): 933-937. Harley BA, Kim HD, Zaman MH, Yannas IV, Lauffenburger DA, Gibson LJ. Microarchitecture of three-dimensional scaffolds influences cell migration behavior via junction interactions. Biophys J. 2008 Oct;95(8):4013-24.
CHAJRA Hanane [18-12-2006] , Mise au point de nouveaux biomatériaux à base de collagène pour la réparation tissulaire cutanée. Development of new collagen-based biomaterials for skin tissue repair
Barbara De Angelis and Coll [29.03.2018]. Long-term follow-up comparison of two different Bi-Layer dermal substitutes in tissue regeneration : Clinical outcomes and histological findings

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SYMATESE AESTHETICS is a sister company of SYMATESE dedicated to design and manufacture of high quality innovative products for plastic surgery.