Introduction

Woman face picture. Technology in designing and projecting prostheses and other surgical and medical aids has today reached a very advanced technical level which is able to guarantee patients the recovery of their locomotorial functions in very short time and with satisfactory results. Nevertheless, the adoption of such systems is often hindered by the unfavourable conditions of the hosting tissues. The Italian company Bioteck^® is a leader in deantigenation systems, and has specialised in the production of biomaterials which derive from natural bone tissue of animal origin. This possibility has been accomplished thanks to an innovative system (patented by the Bioteck^® laboratories) through which the antigens are eliminated from any type of bone tissue. (Universal Bone Tissue Treatment – UBTT).
The preformed products of the FLEX line derive from the production of OSTEOPLANT^® bone tissues. The principal feature of the FLEX bone tissue is, as easily graspable by the name itself, its flexibility to mould and adapt to the grafting area.
This feature makes this bone tissue particularly useful in cranio-facial surgery which, due to the extremely discontinuous morphological conformation of the grafting areas, has always compelled surgeons to turn to synthetic products, often not the best solution for this type of surgery where both functionality and aesthetics are to be pursued.
The demineralisation phase during the process, enables to achieve a bone tissue which can be flexed without crumbling or cracking, therefore, easily adaptable to the anatomical profile of the grafting area. In the production of the FLEX line, Bioteck^® uses tissues of equine origin. Equines are for their nature the mammals that can supply us with large quantities of an ideal bone tissue to be processed following the OSTEOPLANT^® system and transformed into FLEX.

Characteristics

Product name
	OSTEOPLANT^® FLEX (Trade mark).
Production facility
	Bioteck^® S.r.l. Str. Buttigliera, 26 - 10020 Riva Presso Chieri (TO) - ITALY
Product
	Spongy or cortical flexible deantigenic bone tissue, totally reabsorbable, of animal origin (equine).
Deatigenation
	Protein elimination process: selective chemical-enzymatic at 37°C. Demineralisation process: elettrolitic process on apathites accumulation.
Biological nature
	Bone tissue composed by: type I collagen integral bone matrix. mineral bone matrix with non-modified atomic structure.
Metabolization
	Bone physiology by osteoclastic system. The tissue is remineralized in a short time so it maintains constant volumes. Then it will be completely replaced by endogenous bone within 6/12 months. The tissue doesn’t provoke reaction by immunitary system (ISO 10993). The tissue doesn’t provoke the formation of fibrous tissue.
Application fields
	Bone tissue for skeletal cranio-facial reconstruction surgery and for applications not subject to weigh bearing.
Mechanics
	The tissue can be milled and stabilized by means of screws, fibrin glue, suture.
Utilization
	The tissue is supplied in dehydrated form. Before using, rehydrate the product by means of sterile physiological solution. The formats can be laid one on top of the other in order to reach the desired thickness.
Certifications
	CE 0373 issued by the Italian Superior Institute of Health. ISO 10993 granted by the Institute of Physiopathology of Turin University in 1995.

Indications

Indications
	Skeletal apparatus bone defects not subject to weight bearing. Cranio-facial bone defects. Stabilization of OSTEOPLANT^®pre-formats.
Contraindicated
	The product can not be used in bone cavities with infective focus. Before grafting, perform a mechanic and pharmacological decontamination of the cavity.