Avance® Nerve Graft

Avance® Nerve Graft is an off-the-shelf processed human nerve allograft intended for the surgical repair of peripheral nerve discontinuities. Through a proprietary cleansing process for recovered human peripheral nerve tissue, the graft preserves the essential inherent structure of the ECM while cleansing away cellular and noncellular debris.

Avance® Nerve Graft provides the following key advantages:

  • Three-dimensional scaffold for bridging a nerve gap
  • Decellularized and cleansed extracellular matrix that remodels into patient’s own tissue
  • No donor nerve surgery, therefore no comorbidities associated with an additional surgical site
  • Available in a variety of lengths and diameters to meet a range of gap lengths and anatomical needs
  • Supplied sterile with three years shelf life (kept frozen at or below -40º C/F)

regulatory classification

Avance® Nerve Graft is a human tissue for transplantation. Avance® Nerve Graft is processed and distributed in accordance with U.S. FDA requirements for human cellular and tissue-based products (HCT/P) under 21 CFR Part 1271 regulations, U.S. State regulations and the guidelines of the American Association of Tissue Banks (AATB). Additionally, international regulations are followed as appropriate.

This graft is to be dispensed only by or on the order of a licensed physician.

indications for use

Avance® Nerve Graft is a processed nerve allograft (human) intended for the surgical repair of peripheral nerve discontinuities to support regeneration across the defect.

contraindications

Avance® Nerve Graft is contraindicated for use in any patient whose soft tissue implants are contraindicated. This includes any pathology that would limit the blood supply and compromise healing or evidence of a current infection.

warnings

Careful donor screening, laboratory testing, tissue processing and gamma irradiation have been used to minimize the risk of transmission of relevant communicable diseases to the patient. As with any processed human donor tissue, Avance® cannot be guaranteed to be free of all pathogens. Do not reuse or re-sterilize Avance® Nerve Graft and do not refreeze product if thawed.

International distribution

Austria

Crosstec GmbH

Rotenloewengasse 19
1090 Vienna
Austria

Phone: +43 1.310.31.00-0
Fax: +43 1.310.31.00-20

Crosstec GmbH

Spain

Semenza Medical Solutions

Isla Graciosa 2 piso 1 puerta 8
(28703) San Sebastian de los reyes
Madrid, Spain

Phone: +34 91.6636472
Fax: +34 91.6535127

Semenza Medical Solutions

Switzerland

Neutromedics

Alte Steinhauserstrasse
19 CH-6330 Cham
Switzerland

Phone: +41 41.748.04.40
Fax: +41 41.748.04.41

Neutromedics

United Kingdom

Hospital Innovations

Concept House
Talbot Green Business Park
Pontyclun
Rhondda Cynon Taf
CF72 9FG

Phone: +44 29.2002.0858
Fax: + 44 845.8803.555

Hospital Innovations

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