MAGNIFUSE BONE GRAFT PRECLINICAL EVIDENCE Bone Grafting (Spine and Orthopaedic)

Evaluation in Rat Two-Level Spinal Fusion Model (8 Weeks)*

  • More challenging than traditional 1-Level
  • Athymic rats
  • Uninstrumented
  • Bilateral decortication, dorsal surfaces of transverse processes
  • L3, L4, and L5
  • Test article: Paraspinal TPs, L3–L5
  • Sacrifice: 8 weeks
  • Contact X-ray, Palpation, Histology
  • Manual palpation: 100% fused
  • X-ray: 100% fused

Evaluation in Rabbit Posterolateral Spine Fusion Study*

  • Single-level fusion L4/L5 New Zealand white rabbits
  • Grafts – Magnifuse™ II – Autograft
  • Implantation time – 8 weeks
  • Number of specimens: 6 per group (12 segments)
  • Bone formation assessment:
    • X-ray
    • Manual palpation

Magnifuse II DBM (provided allograft and recovered autograft):

  • Palpation: 100% fused
  • X-ray: 100% fused

Autograft only:

  • Palpation: 83% fused
  • X-ray: 83% fused
X-ray Image of Rabbit Bone Graft

CONTRAINDICATIONS

The following are contraindications for the use of Magnifuse™ DBM Bone Graft and Magnifuse™ II Bone Graft:

  • The presence of infection at the transplantation site.

CAUTION

This product may contain trace amounts of antibiotics (gentamicin), surfactant, and other solutions used in processing the bone tissue as well as the PGA mesh. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.

For more details see Indications, Safety, and Warnings.


*

Data on file. Animal studies are not necessarily indicative of human clinical outcome.