Textile invasive and non-invasive medical devices
Researches conducted in the field of invasive medical devices impose the need to elaborate new technological solutions of high complexity, able to lead to the achievement of some textile invasive and non-invasive medical devices, capable to assure bio-functional and bio-medical performances supposed by their clinical application fields, respectively: biocompatibility with human tissue, chemical inertness correlated with functional properties maintenance on their entire lifespan, proper dimensional stability, non-cancerous effects, maximal resistance and sustainability, adaptability, flexibility, protection against infections, radio-transparency, porosity and permeability adequate to the neo-tissue development, intra-surgery modeling properties, lack of disintegration phenomenon, so that to assure the incorporation into host tissues free of emergent problems etc.
Invasive and non-invasive medical devices made of textile and plastic materials achieved by I.N.C.D.T.P. represent an absolute novelty on national plan, their originality character being conferred by products overall conception in accordance with exigencies specific to application. The most defining features are – the type of raw material, the elaboration and design of the textile supports meant for the mentioned structures, geometrical and technical characteristics, proper correlation of technological conditions related to finishing-sterilization stages – so that level imposed by international standards for the physical-chemical, biological and micro-biological characteristics of this category of products (minimal 90 days time contact with human tissue) to be assured.
On national plan, there is no company or institute, with an R&D profile, that have preoccupations in the field of invasive and non-invasive medical devices made of textile materials.
At present, these products are imported from manufacturing companies in France, USA, Japan, etc.
I.N.C.D.T.P. is the only organization having preoccupations in the field of research and production put in place for the invasive and non-invasive medical devices made of textile materials and meant for various surgical sectors: neural-surgery, gastro-entherology, plastic and reconstructive surgery, cardio-vascular surgery.
All the medical items are achieved in collaboration with physicians, world acknowledged specialists, clinical studies being carried on in specialty clinics notified by the Ministry of Health in Romania.
Pre-clinical studies related to these products, as well as their attesting and certification are performed by a Body accredited by the Ministry of Helath – OTDM SVIAM.