Implantation with Histopathology Tests

Implantation with Histopathology tests is designed to assess the local effects at a gross and microscopic level on tissues at the implant site induced by a sample of a material or medical device. For devices intended to implant into the body, implantation with histopathology tests is required as a biocompatibility assessment. This test is suitable for solid/non-absorbable, non-solid including porous materials, liquids, gels, pastes, and particulates or degradable and/or absorbable (which may be solid or non-solid) devices.

General Test Procedures

Cut the samples of medical devices or bio-materials to size, if necessary; sterilized, and implanted aseptically. After a period of time ranging from weeks to months, the testing service is conducted to examine the implant sites. A complete necropsy is performed to evaluate systemic effects, local effects, lymph nodes, fluids (blood, etc.), and filtration/ detox organs (liver, kidneys, brain – arterial circulation, lungs – venous circulation).

"Tests for Local Effects after Implantation", part of the biocompatibility standards(ISO 10993-6), gives out the widespread considerations that should be born in mind when performing implant studies. It outlines the selection of species, appropriate tissues for implantation, the length of time implants should remain in place, implantation methods, and the evaluation of biological responses.

What Can We Do

STEMart offers Implantation with Histopathology tests to assess the local pathological effects of medical device or bio-materials on living tissue, following the biocompatibility guidelines modified for medical devices. Studies can be customized to build on species, animal number, implant site, implant duration, and evaluation criteria.

Implant Site Capabilities

• Muscle
• Subcutaneous
• Bone
• Brain
• Dermal
• Ocular
• Intraperitoneal
• Customized implants
• For short-term (ranging from 2 to 12 weeks) implantation evaluation:

  Animals used in these studies are mice, rats, guinea pigs, or rabbits.

• For longer-term (more than 12 weeks) testing in subcutaneous tissue, muscle, or bone.
• Animals used in these studies are generally rabbits, dogs, sheep, goats, pigs, and other animals with relatively long life expectancy.

We compare the tissue response induced by the test sample with that induced by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established to evaluate the local effects. The test can characterize the history and evolution of the tissue response and the final integration or absorption/degradation of the medical device/biomaterial after implantation.

The Implantation with Histopathology tests, help you to determine the safety and biocompatibility of medical device, and it also can be used as a screening tool for the development of implant with specific characteristics such as porous surface to promote ingrowth, coating to prevent cell attachment, anti-microbial coatings and stimulation of specific cells. If you have additional questions about Implantation with Histopathology tests or would like to find out more about our services, please feel free to contact us.