Project Description

High V+® Spinal Cement System

High viscosity spinal bone cement with mixing & injection system

HighV+® Spinal Cement System is a kit which includes high viscosity bone cement and a mixing and injection system specifically designed to withstand high pressure.

Its main advantage is to reduce the risk of leakage occurence during vertebroplasty and kyphoplasty procedures.

PRODUCT

HighV+® Spinal Cement System is an assembly of 3 devices:

  • HighV+® Radiopaque Bone Cement
  • HighV+® Mixing System
  • HighV+® Injection System

HighV+® bone cement is intended for use in palliative percutaneous cementoplasty procedures such as vertebroplasty or kyphoplasty.

For the USA market, fenestrated screw manufacturers can apply for FDA clearance for their screws in conjunction with HighV+®.

HighV+ Radiopaque Bone Cement:

Thanks to its very high viscosity HighV+® bone cement is ready to be injected immediately after the transfer into the injection syringe.

HighV+ Mixing System:

An intuitive Mixing System with an epicycloidal movement mixing blade to get a homogenous blend.
• Easy to use system
• Transparent system allowing the user to see the mixing process.
• Closed sytem, the user is never in contact with the cement.

HighV+ Injection System:

The High Viscosity Injection System is a hydraulic injector, to be filled with sterile water*
• The hydraulic injector is the only way to have enough pressure to delivery the HighV+® bone cement.
• All the volume of the bone cement within the syringe can be injected.
• A long hydraulic line is provided to reduce exposition to x-rays.

*Sterile water not included

HighV+® can be associated with Teknimed vertebroplasty needles.

References

Designation
 Reference
HighV+® Spinal Cement System (Bone cement & Delivery system) 
 T040321K

Bibliography

Vasileios S Nikolaou, Demetrios Korres, Stergios Lallos, Andreas Mavrogenis, Ioannis Lazarettos, Ioannis Sourlas, Nicolas Efstathopoulos, Cemented Müller straight stem total hip replacement: 18 year survival, clinical and radiological outcomes, World J Orthop 2013 October 18; 4(4): 303-308, doi:10.5312/wjo.v4.i4.303

Sun Hong Kim, M.D., Hyuk-Soo Han, M.D., Ph.D., Do Hoon Kim, M.D. and Seung-Baik Kang, M.D., Ph.D, Two-Stage Reimplantation in Infected Total Knee Arthroplasty (A Method of Reinsertion of the Autoclaved Femoral Component and a Polyethylene Liner), J Korean Knee Soc, Vol. 22, No. 2, June 2010