|
The SIS manufacturing process has been validated to ensure that any
virus that might be present in source animals is completely inactivated.
SIS has been rigorously tested to confirm that it is biocompatible.
| Genotoxicity |
[ ]
Pass |
|
| Hemocompatibility |
[] Pass |
|
| Cytotoxicity |
[]
Pass |
|
| Muscle
Implantation |
[] Pass |
|
| Skin
Irritation |
[]
Pass |
|
| Acute
Intracutaneous Reactivity |
[] Pass |
|
| Repeat
Exposure Sensitization |
[]
Pass |
|
| Acute
Systemic Toxicity |
[] Pass |
|
| Subchronic
Systemic Toxicity |
[]
Pass |
|
| Pyrogenicity |
[] Pass |
|
| Endotoxins |
[]
Pass |
|
Testing performed by accredited, independent testing laboratory using testing methods based on international standards and FDA guidance.
In vitro test results show that the human complement cascade is not activated
following exposure to SIS, demonstrating that SIS does not
elicit a rejection response.
| Material |
Complement
Activation*
(ng/ml) |
|
| Negative
Control |
148±42 |
|
| SIS
Material |
115±24 |
|
| Positive
Control |
2449±930 |
|
* Assay for C3a protein
McPherson TB, et al. Tissue Engineering, 2000; 6: 233-239.
Numerous steps have been taken to ensure the safety of SIS. These
include:
- Strict control of source animals.
- Certified animal production facilities.
- Use of a validated disinfection process to produce SIS.
- Terminal sterilization of all medical products.
- Independent laboratory testing to verify biocompatibility of the
material.
- Extensive, non-clinical testing.
 back |
 top |
learn more 
|
