Project Description

OPACITY+®

PMMA bone cement for vertebroplasty and kyphoplasty

OPACITY+® is a low viscosity radiopaque bone cement for vertebroplasty, allowing excellent stabilisation of the vertebral body.

The very high concentration of zirconium oxide in this cement allows it to be used during vertebroplasty procedures during which continuous radiological monitoring is performed using a scanner or image intensifier. The operator can then immediately follow the flow of cement from the very beginning of filling of the vertebral body, so avoiding the risks of leaks, the most frequently-encountered problem during vertebroplasty procedures.

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

ADVANTAGES

  • Easy to handle
  • Low viscosity
  • Biocompatibility
  • High radio-opacity
  • 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).

This product is not intended to treat, cure, or prevent any cancer.

Hardening

Thanks to its initial low viscosity, OPACITY+ ® can be mixed very easily in 45 sec and tranfered into injection system. A few minutes after beginning mixing, the cement reaches an average viscosity level ideally suited to a vertebroplasty procedure.

The viscosity has been specifically developed for application in vertebroplasty: OPACITY+ ® can be injected easily, using an injection kit such as the S5 and a G11 or 13 needle, into the vertebral body, while avoiding cement leakages outside the vertebral body.

From the start of mixing, the operator has 12.5 minutes to apply the cement to the vertebral body. This is more than sufficient to conduct continues radiological checks and perform a several filling operations over a periode of time, thereby avoiding any undesirable migration of the cement.

 

Mechanical properties

The mechanical properties of OPACITY+ ® cement are superior to standard ISO 5833

Description Reference
Kit S5 ® T060410
EASY KIT ® T060409
MINIMALAX ® T060406
TROCAR TEKNIMED T060406 – T060431 – T060432T060433 – 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.