Product Overview
IsoTis® Pure Strips are 100% human allograft, composed of demineralized bone matrix and donor-matched musculoskeletal tissue. The implants are designed specifically for use in lumbar fusion procedures.
Key Features
Verified Osteoinductive Potential - Each lot is tested for osteoinductive potential1 following terminal sterilization. The demineralized Bone Matrix (DBM) is sterilized through the Cancelle® SP DBM sterilization process, which is designed to preserve naturally occurring proteins and physical structure of the tissue. Each lot is tested for osteoinductive potential following terminal sterilization.
Flexible Handling - The hydrated graft is pliable – able to be folded, twisted and molded. Bends to conform to the defect site and make contact with the decorticated bone. The graft is cohesive and maintains integrity during irrigation.
Hydration - Alternative hydration options provide flexibility. Reduce hydration time to achieve firm yet pliable handling. Hydrate with sterile saline, sterile water, blood, bone marrow aspirate (BMA) or platelet rich plasma (PRP). Hydrating fluid is retained within the implant at the graft site.
Highest Level of Safety - The highest level of safety is ensured through redundant safeguards, including tissue and DBM sterilization processes and terminal sterilization by low-temperature, low-dose gamma irradiation.
1DBM or representative finished implant is either assayed in vivo in the modified athymic nude rat for bone formation or in vitro for endogenous BMP-2 as a surrogate test marker for osteoinductive potential. Because the combination of various proteins is responsible for osteoinductive potential, DBM when assayed in vitro, is also screened for the presence of BMP-7. Findings from an in vitro assay or animal model are not necessarily predictive of human clinical results. (https://www.seaspine.com)
