VertaPlex HV bone cement
VertaPlex HV bone cement is used for treating vertebral compression fractures. It reaches a thick viscosity as soon as it’s mixed and maintains viscosity for an average of 18 minutes.1
VertaPlex HV cement was introduced in 2009 to address specific viscosity and working time preference for physicians. In 2015, VertaPlex HV became the first polymethylmethacrylate (PMMA) cement in the U.S. to receive 510(k) clearance for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty.
Features
- Immediate high viscosity after mixing1
- Controlled interdigitation and fill with citation reference number2
- Working time of approximately 18 minutes1
- Set time 10.2 at 37C2
- Low creep rate2
- Increased viscosity improves visibility2
- 30% barium sulfate concentration
Warning/adverse events
Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.
References:
- Independent lab results from Fluid Dynamics Inc commissioned by Stryker (July 2009). Testing conducted at 20-21 ˚C (68-70 ˚F).
- Stryker data on file for the source information
IVS-VPHV-SYK-1135417_REV-0