Biocompatibility testing of tissue engineered products.

The discipline of Tissue Engineering has developed over the past 15–20 years as a compilation of the emerging technologies in regenerative medicine and reconstructive surgery, holding the promise of surpassing the limitations imposed by the biomaterials currently available. By utilizing the regenerative capacity of tissues it is anticipated that functional tissue analogues having the desired dimensions, mechanical attributes (such as strength, compliance, etc.) and enduring biological function can be deployed giving device, organ or tissue integration that overcome the potential problems of inflammation, immune response, tumorigenicity and device failure that purely synthetic systems can cause. Although many billions of dollars have been invested in tissue engineered products world-wide, viable products have so far only been marketed in the skin and skeletal tissues. Current research will soon bring to the market cardiovascular devices that, by their very nature hold greater risk to the patient. The specific issues relevant to cardiovascular tissue engineered products are described in detail below.