ViviGen ® and ViviGen Formable ®

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Instructions for Use
Product Specifications

ViviGen ® and ViviGen Formable ®

ViviGen ® and ViviGen Formable ®

Cellular Bone Matrix

ViviGen represents a paradigm shift in the field of bone repair and tissue engineering by focusing on lineage committed bone cells. At every step of ViviGen’s processing,  LifeNet Health has focused on maintaining the highest level of bone cell viability. ViviGen is a 361 Human Cells, Tissues, and Cellular
and Tissue-based Product (HC/P) comprised of cryopreserved corticocancellous bone containing endogenous lineage committed bone cells combined with demineralized  bone delivering all three properties necessary for bone formation.

  • Osteogenic - Contains viable, lineage committed bone cells that are able to proliferate in vitro1 post cryopreservation and thaw
  • Osteoconductive - Contains corticocancellous chips that provide a natural scaffold for cell attachment, cell migration, and cell proliferation
  • Osteoinductive Potential - Demineralization of the cortical bone exposes the natural growth factors within the matrix1
  • Safety - Every lot is aseptically processed and all final product is tested for sterility using USP<71> standards
  • Packaging - The rapid heat transfer not only allows for all sizes to thaw in less than 5 minutes, but is also vital for cell viability
  • Processing Time - ViviGen reaches cryopreservation within 72 hours, maximizing cell viability 24 hours sooner than competitive products
  • Maximized Cell Viability - The processing of ViviGen is focused on protecting viable, lineage committed bone cells from recovery to implantation
  • Multiple Forms - ViviGen and ViviGen Formable provide a comprehensive solution to meet surgeons’ clinical needs
Clinical Application
  • Arthroplasty
  • Limb salvage procedures
  • Bone fusion applications for trauma and extremities
  • Fusions for deformity and degenerative applications in the cervical and thoracolumbar spine
Frozen Description Sizing
BL-1500-001 ViviGen 1cc
BL-1500-002 ViviGen 5 cc
BL-1500-003 ViviGen 10 cc
BL-1500-004 ViviGen 15 cc
BL-1600-001 ViviGen Formable Small (1.3 cc)
BL-1600-002 ViviGen Formable Medium (5.4 cc)
BL-1600-003 ViviGen Formable Large (11.0 cc)
BL-1600-004 ViviGen Formable X-Large (16.0 cc)
References
  1. Data on File at LifeNet Health 65-0347.