GRAFTYS® QUICKSET

About

Not applicable to US Spine market

GRAFTYS® QUICKSET is a safe and efficient synthetic biomaterial. This unique product is a patented phosphocalcic, macroporous, injectable, hardening, and resorbable cement. Its physicochemical structure confers suitable osteoconductive properties adapted to spine fusion (eg : Spine fusion 360°). GRAFTYS® QUICKSET pro vides excellent cohesiveness and short setting time (8 minutes), which are especially helpful in bloody or open cavities...the implant will stay in place.

Composition

The powder mineral phase is a premeasured combination of calcium phosphates including an organic phase polysaccharide) which confers wettability and porosity to facilitate percolation of the body fluids throughout the implant and improves the cohesion, elasticity, and injectability. The liquid phase (sodium phosphate solution) allows homogenous mixing and reproducible setting time (crystallization) of the cement. After complete hardening the final product is comprised of apatite crystals, similar to native bone crystals.

Physicochemical properties

Global Porosity : 70% distributed as below:
Micro porosity (pores <10 µm): 88%;
Meso porosity (10 - 100 µm): 2%;
Macro porosity (>100 µm): 10%

No shrinkage during the crystallization process. Non exothermic reaction: 1-3 °C. Mechanical compressive strength: 24MPa (24 hours after implantation). This product has to be used in an intrinsic stable site or in association with material which will stabilize the surgical site. Cohesiveness: Excellent resistance to fluid.

Preparation

GRAFTYS® QUICKSET provides an easy, closed mixing system (which eliminates the messy bowl/spatula). A rotating valve system on injection end of syringe is shipped in "Closed" position. To initiate mixing, hold injection end upright and rotate ring to "Transfer". Press fluid into the powder side. Mix thoroughly for 2 minutes. Rotate ring to "Inject" and inject the material directly by hand or with injection gun.

Performance table

- Mixing time (room temperature): 2 minutes
- Injection time (room temperature): 2-4 minutes
- Diameter of usable cannula: ≤7 G
- Low sensitivity to temperature variations of a functional operating room
- Initial setting time (37°C -98°F body temperature in biological conditions): 8 min
- Complete hardening (37°C -98°F body temperature in biological conditions): 24 hours

Mechanism of action

GRAFTYS® QUICKSET is a macroporous, injectable, hardening,and resorbable cement. The mineral part allows the formation of a close bond with native bone and take advantage of locally present osteogenic proteins. Its structure is gradually resorbed via cells participating to the natural bone remodeling cycle. Conduction and formation of new mineralized healthy bone is thereby ensured as the material resorbs without void formation (rapid dissolution can create fibrosis). The organic part confers wettability and porosity to facilitate percolation of body fluids throughout the implant and essentially improves the cohesion, elasticity, and injectability.

Features