BioSurgery

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100% Synthetic Autograft Alternative

ACTIFUSE is a 100% synthetic, osteostimulative bone graft substitute. An autograft alternative without the complications of a secondary surgery site2,8, the ACTIFUSE patented silicate substitution process has demonstrated success.9

The ACTIFUSE family of products has been designed with the surgeon in mind to provide control of bone graft placement throughout the surgery. Effective in a variety of surgical procedures, the distinct handling characteristics and delivery methods of ACTIFUSE provide surgeons with the right choice for controlled delivery, precise placement and effective results during and after surgery.

ACTIFUSE is contraindicated where the device is intended as structural/loadbearing support in the skeletal system.

Demonstrated Performance

Quantitative CT demonstrates total fusion volume against time in a clinically relevant ovine PLF model.2

2010 Actifuse Demonstrated Performance Graph with lines

Accelerated Bone Formation


ACTIFUSE combines an interconnected macro- and micro- porous structure with osteostimulative chemistry created through a patented silicate substitution process to attach and stimulate osteoprogenitor cells (OPCs) and mesenchymal stem cells (MSCs), accelerating bone growth.1,3

Effectiveness Through Structure and Chemistry

Macro and Micro Porosity

Through a proprietary manufacturing process, the micro porosity and macropores of ACTIFUSE are created, mimicking human bone.4,6,14

Human bone and ACTIFUSE

Optimal Physiochemistry- 0.8 wt% Silicon Proven to be Optimal for Accelerated Bone Formation5

ACTIFUSE mimics the composition of human bone with the optimal 0.8% silicon by weight, which is similar to the level identified in naturally-growing bone4, enhancing osteoblast and hMSC attachment, and protein adsorption.3,7

2010 Actifuse Optimal Physiochemistry Graph with error lines

Physiologically Mediated Resorption

The resorption rate of ACTIFUSE is physiologically appropriate: like human bone, ACTIFUSE is remodeled via osteoclastic resorption rather than chemical dissolution.1   ACTIFUSE provides a stable scaffold for as long as the bone healing process requires it.1

Safety Profile

ACTIFUSE is a purely synthetic, sterile, and consistent bone graft; it mitigates disease transmission.

ACTIFUSE is contraindicated where the device is intended as structural/load bearing support in the skeletal system.

Distinct Handling Characteristics

  • Variety of formulations Designed for Surgical Control
  • Resists irrigation and compression10,11
  • Ready to Use- no mixing or preparation required12
  • No special storage required12
  • Clearly Viewed on X-ray13

Important Risk Information for ACTIFUSE

ACTIFUSE is contraindicated where the device is intended as structural/load-bearing support in the skeletal system.

ACTIFUSE has not been cleared for use in vertebroplasty.

Other conditions representing contraindications include: severe vascular or neurological disease; uncontrolled diabetes; severe degenerative disease; uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol; hypercalcemia, abnormal calcium metabolism; existing acute or chronic infections, especially at the site of the operation; inflammatory bone disease such as osteomyelitis; malignant tumors; severely impaired renal function.

Attempts should not be made to modify the size of the granules or to change their shape. It is important to maximize contact between existing bone and the implant to ensure proper bone regeneration.

The graft must be secured to prevent potential migration and should only be used in surgical procedures where bone grafts are adequately contained. Do not overfill or attempt to pressurize the bony defect site, as this may lead to extrusion of the product beyond the site of its intended application and damage the surrounding tissues, or may lead to fat embolization or embolization of the device into the bloodstream. The effect of mixing ACTIFUSE with substances other than sterile saline/water, autologous blood, or bone marrow aspirate is unknown.

ACTIFUSE Bone Graft Substitute
Silicate Substituted Calcium Phosphate

ACTIFUSE is a bone void filler intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.  Actifuse is also intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects, including periodontal, oral, and craniomaxillofacial applications.

ACTIFUSE is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis and spine including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.  The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Order Information

Order # Description
 506005078060 ACTIFUSE ABX Bone Graft Substitute 1.5 mL
 506005078050 ACTIFUSE ABX Bone Graft Substitute 2.5 mL
 506005078051 ACTIFUSE ABX Bone Graft Substitute 5 mL

 506005078052

ACTIFUSE ABX Bone Graft Substitute 10 mL
 506005078058 ACTIFUSE ABX Bone Graft Substitute 20 mL
 506005078070 ACTIFUSE MIS System Applicator + Cartridge 7.5 mL
 506005078072 ACTIFUSE MIS System Refill Cartridge 7.5 mL
 506005078062 ACTIFUSE Shape Bone Graft Substitute Small Cylinder
15 mm D X 9 mm
 506005078064 ACTIFUSE Shape Bone Graft Substitute Medium Cylinder 15 mm D X 15 mm
 506005078066 ACTIFUSE Shape Bone Graft Substitute Large Cylinder
15 mm D X 45 mm
 506005078068 ACTIFUSE Shape Bone Graft Substitute Large Strip
90 mm X 25 mm x 7 mm
 506005078028 ACTIFUSE Granules Bone Graft Substitute 5 mL
 506005078029 ACTIFUSE Granules Bone Graft Substitute 10 mL
 506005078030 ACTIFUSE Granules Bone Graft Substitute 20 mL
 506005078056 ACTIFUSE Granules Bone Graft Substitute 30 mL
 506005078044 ACTIFUSE Microgranules Bone Graft Substitute 2.5 mL
 506005078045 ACTIFUSE Microgranules Bone Graft Substitute 5 mL
 506005078046 ACTIFUSE Microgranules Bone Graft Substitute 10 mL

References:

  1. Hing K. et al. Comparative performance of three ceramic bone graft substitutes, The Spine Journal 2007; 7(4): 475-490.
  2. Wheeler D. et al. Efficacy of silicated calcium phosphate graft in posterolateral lumbar fusion in sheep, Spine J. 2007; 7(3): 308-317.
  3. Baxter data on file.
  4. Carlisle E. et al. Silicon: A Possible Factor in Bone Calcification. Science. 1970; 167.(3916):279-280.
  5. Hing K. Revell PA, Smith N, Buckland T. Effect of silicon level on rate, quality and progression of bone healing within silicate-substituted porous hydroxyapatite scaffolds. Biomaterials. 2006;27(29):5014-5026.
  6. Baxter data on file.
  7. Baxter data on file.
  8. Kim D, Rhim R, Li L, et al. Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009; (9): 886-892.
  9. Jenis L, Banco R. Efficacy of silicate-substituted calcium phosphate ceramic in posterolateral instrumented lumbar fusion. Spine 2010;35(20):E1058-E1063.
  10. Baxter data on file.
  11. Baxter data on file.
  12. ACTIFUSE Instructions for Use.
  13. Baxter data on file.
  14. ACTIFUSE Patent, EP117626B2.