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NAMSA

ISO Muscle Implantation Study

Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical devices or bio-materials.  The implant location is based on the clinical site of use.  Implant duration’s are based on the need to evaluate the tissue response over multiple intervals and along with the sample’s inertness and absorptive characteristics

This implant study involves placement of a portion of a test article in the para-vertebral muscle.  A negative control is also implanted.  Following  the listed time of implantation, sites are collected, slides prepared and a microscopic  evaluation performed to determine the extent of a local tissue response.

Test Options/Variations

TI250-001 with Sponsor Control - 1 Wk
TI250-002 with Sponsor Control - 2 Wk
TI250-003 with Sponsor Control - 3 Wk
TI250-004 with Sponsor Control - 4 Wk
TI250-006 with Sponsor Control - 6 Wk
TI250-009 with Sponsor Control - 9 Wk
TI250-012 with Sponsor Control - 12 Wk
TI250-026 with Sponsor Control - 26 Wk
TI250-052 with Sponsor Control - 52 Wk
TI250-801 1 Wk
TI250-802 2 Wk
TI250-803 3 Wk
TI250-804 4 Wk
TI250-806 6 Wk
TI250-809 9 Wk
TI250-812 12 Wk
TI250-826 26 Wk
TI250-83R 3 Subject, Variable Interval
TI250-84R 3 Subject, Variable Interval
TI250-852 52 Wk