SPINE FIX® 2017-10-24T15:20:18+00:00

Project Description

SPINEFIX®

PMMA bone cement for vertebroplasty and kyphoplasty

SPINEFIX® and SPINEFIX® US (only sold in the US market), manufactured according to standard ISO 5833, are low viscosity, radio-opaque cements for vertebroplasty and kyphoplasty.

The high concentration of barium sulphate in this cement enables it to be used during vertebroplasty procedures. Indeed, it perfectly responds to the high level of visualisation and safety required during percutaneous vertebral augmentation procedures.

In addition, both the viscosity and setting time have been specifically developed for application in vertebroplasty: SPINEFIX® can easily be injected using a needle into the vertebral body.

The relatively long setting time for this cement gives the surgeon enough time to inject it safely into the vertebral body.

SPINEFIX® comes as an ampoule of sterile liquid and a pouch of sterile powder (liquid monomer and powder polymer).

ADVANTAGES

  • Radio-opaque
  • Low viscosity
  • Biocompatibility
  • Application time 10 min
  • Low exothermicity

References

Description Reference
SPINEFIX® – SPINEFIX® US T040320S – US040320S

Certifications

CE: 0086
Classe : IIb

SpineFix® US: The device is only cleared to be sold in US market

Bibliography

Anselmetti, G. C., A. Manca, et al. (2009). « Temperature measurement during polymerization of bone cement in percutaneous vertebroplasty: an in vivo study in humans. » Cardiovasc Intervent Radiol 32(3): 491-8.
Anselmetti, G. C., G. Corrao, et al. (2007). « Pain relief following percutaneous vertebroplasty: results of a series of 283 consecutive patients treated in a single institution. » Cardiovasc Intervent Radiol 30(3): 441-7.