Project Description

OPACITY+®

Bone Cement for Vertebroplasty & Kyphoplasty

OPACITY+® is a self-curing and ready to use low viscosity bone cement with a very high content of radiopaque agent for a perfect and safety visualization.

Its composition has been optimized to get the most suitable handling properties for vertebroplasty & kyphoplasty.

ADVANTAGES

  • Easy to handle
  • Low viscosity
  • Biocompatibility
  • High radio-opacity
  • Injection time : 13 mn
  • Suitable working time

OPACITY+® is indicated for the fixation of pathological fractures of vertebral body (vertebroplasty and kyphoplasty).

Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

PHYSICO-CHEMICAL COMPOSITION
PMMA bone cement made of polymer powder containing HA particles and liquid monomer.

BIOCOMPATIBLE
5% hydroxylapatite particles in OPACITY+® provides a biocompatible surface.

EASY INJECTION
The initial low viscosity makes easier the mixing and filling of the injection system. The OPACITY+® is injectable through a small gauge needle.

VISCOSITY
The OPACITY+® is low viscosity, providing more homogenous bone filling with minimizing leakage potential.

RADIO OPACITY
OPACITY+® has an increased radiopacity agent (50%) for maximum visibility and control. Better contrast allows improved continuous real time view of the flow of cement, reducing risk of leakage. Can be used either under fluoroscopy or CT scan.

Description Reference
Kit S5 ® T060410
EASY KIT ® T060409
MINIMALAX ® T060406
TROCAR TEKNIMED T060430 – T060431 – T060434 – T060435

References

Description Reference
OPACITY+ ® T040320Z

Certifications

CE 2797
The device is cleared to be sold in US market.
Classe : IIb

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.
Muijs, S. P., M. J. Nieuwenhuijse, et al. (2009). « Percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression fractures: evaluation after 36 months. » J Bone Joint Surg Br 91(3): 379-84.
Afzal, S., S. Dhar, et al. (2007). « Percutaneous vertebroplasty for osteoporotic fractures. » Pain Physician 10(4): 559-63.