ACTIFUSE [Bone Graft Substitute] Silicate Substituted Calcium Phosphate
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Instructions for Use
The information contained in this page is intended for U.S. healthcare professionals only.
ACTIFUSE [Bone Graft Substitute] Silicate Substituted Calcium Phosphate is a 100% synthetic, osteostimulative bone graft substitute. It is an autograft alternative without the complications of a secondary surgery site2,8. The ACTIFUSE family of products has been designed to provide control of bone graft placement throughout the surgery. Effective in a variety of surgical procedures.
Family of Products: ACTIFUSE MIS System; ACTIFUSE ABX; ACTIFUSE Shape; ACTIFUSE Granules and ACTIFUSE Mocrogranules
Indications & Usage
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.
ACTIFUSE has not been cleared for use in vertebroplasty.
Features
- ACTIFUSE accelerates bone growth by combining 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).1,2,9
- 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 bone3, enhancing osteoblast and hMSC attachment, and protein adsorption.2,4
- ACTIFUSE has a physiologically appropriate resorption rate: 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
- ACTIFUSE is a purely synthetic, sterile, and consistent bone graft, mitigating disease transmission.
- The ACTIFUSE Family of Products includes a variety of formulations designed for surgical control.
- ACTIFUSE resists irrigation and compression5,6
- ACTIFUSE is ready to use, no mixing or preparation required7
No special storage required7 - ACTIFUSE can be clearly viewed on x-ray8
Important Risk Information
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.
References
1. Hing K. et al. "Comparative performance of three ceramic bone graft substitutes", The Spine Journal 2007; 7(4); 475-490.
2. Baxter data on file.
3. Carlisle E. et al. "Silicon: A Possible Factor in Bone Calcification", Science 1970; 167.3916.279.
4. Baxter data on file.
5. Baxter data on file.
6. Baxter data on file.
7. ACTIFUSE Instructions for Use.
8. Baxter data on file.
9. ACTIFUSE Patent.
