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Model


Sub-cutaneous Implantation

Basics


Test materials compared to standards & competitor materials

Surface photography of implantation sites at regular intervals

Implant site assessed at various time points after implantation

Gross inspection & documentation (e.g. photography) of implant sites

Histological/biochemical assessment to determine bio-compatibility & bio-degradability

Documentation of adverse/unexpected events through the study

Study period – up to a maximum of 12 months

Assessments
Bio-Compatibility - assessment of the tissue response to the presence of the implant and/or  any degradation products – in terms of:-  

v
  extent & duration of the inflammatory response
v
  extent & form of cellular ingress
v
  extent of foreign body reaction development
v
  extent of peri-implant fibrous encapsulation    

biocompatibility histology
















Bio-Degradability - assessed in terms of the amount of implant material remaining with time after implantation. Determined from gross and/or histological images
biocompatibility biocompatibility
No response to product A
Significant response to product B
Applications


Widely used bio-medical model


Valuable performance & safety data


Bio-compatibility and longevity of products/scaffolds


The impact of inadvertent entrapment of dressing materials in wounds
Navigation
Pre-clinical research -Bio-Compatibility & Bio-Degradation
Wound Healing Models Physical Testing Protease Regulation / Modulation Anti-Microbial Efficacy Testing Haemostat Assessment Bio-compatibility / degradation
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