nevelia®

NEVELIA® dermal regeneration template is used to reconstruct the dermis following a skin loss.

NEVELIA® dermal regeneration template is a sterile medical device consisting of a collagen layer to promote dermal regeneration and a reinforced silicone layer acting as a pseudo-epidermis.

The key features of NEVELIA® have been developed to achieve dermal reconstruction close to native skin thanks to:

• Our expertise in the field of SKIN AND DERMAL REGENERATION

• Our SCIENTIFIC APPROACH to development and manufacturing

• Our know-how in COLLAGEN TRANSFORMATION

Properties

 

The bovine collagen type I, purified, stabilized, is supplied as a porous matrix. This dermal regeneration template serves as a support for cell infiltration and as a collagen matrix dressing, thus contributes to the natural tissue regeneration process. It is resorbed, becoming a vascularized tissue that is histologically very close to the normal dermis, from 2 to 3 weeks after it is implanted. The silicone layer is removed after dermal regeneration, at the time of the thin split thickness skin graft.

NEVELIA® is a three-dimensional porous matrix of stabilized bovine Collagen type I. NEVELIA® is made of a specific native collagen type I 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.

Additional NEVELIA® features are:
• Optimized pore size (average pore size 100 μm) and open-cell structure promoting nutrients flow and fibroblasts migration
• Crosslinking rate for a balanced absorption / regeneration process
• No GAG added to keep cells attachment potential

NEVELIA® MATRIX-SEM photography

OTHER BI-LAYER MATRIX-SEM photography

NEVELIA® 

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

OTHER BI-LAYER MATRIX

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

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

NEVELIA® 
Reinforced silicone sheeting

 

OTHER BI-LAYER MATRIX
Non-reinforced  silicone sheeting

 

Indications

 

NEVELIA® Bi-Layer Matrix 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® dermal regeneration template is used in combination with a thin split thickness skin graft (STSG) to recreate skin resembling normal skin in terms of function and appearance.

Use

N

Burns

N

Chronic wounds

N

Traumatology

N

Skyn tumors

N

Others

NEVELIA® can also be used in children.

NEVELIA®, AN ALTERNATIVE TO :

Skin Expansion (Single or sequential)

Flaps (Local, distant, free …)

Split-Thickness or Full-Thickness skin autograft

Dermal graft (Allografts, Xenografts…)

Clinical benefits for specific indications

[

BURNS SURGERY

Waiting donor site availability for extended burns

[

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 anatomo-pathologist results. Facilitates monitoring of cancer recurrence. Ease of care for the elderly through faster mobilization

Additional benefits

NEVELIA® bi-layer matrix can 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)

Presentation and size

This dermal regeneration template is presented in 4 sizes:

REFDESCRIPTION SIZEUNITS
MCS0505NEVELIA® Bi-layer Matrix
for dermal regeneration
5×5 cm1
MCS1015NEVELIA® Bi-layer Matrix
for dermal regeneration
10×15 cm1
MCS1030NEVELIA® Bi-layer Matrix
for dermal regeneration
10×30 cm1
MCS2030NEVELIA® Bi-layer Matrix
for dermal regeneration
20×30 cm1

NEVELIA® dermal regeneration template is supplied -hydrated between two protective sheets of plastic in double pouches. Each pack contains one bi-layer matrix and is radiation-sterilized.

NEVELIA® dermal regeneration template is CE marked by the notified body G-MED n°0459 and is a Class III Medical Device made by SYMATESE – Chaponost – FRANCE

For full list of recommendations for use and contra-indications, method of administration, especially in Reconstructive plastic surgery please refer to the Instruction For Use of the product included in the box.

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