Vertebral Fractures
The cause of vertebral fractures is represented by osteoporosis (70%), followed by causes of an oncological nature (20%) and causes of a traumatic nature (10%).
These are just some of the numbers that led the O.M.S. – the World Health Organization – to consider osteoporosis the main pathology on which to concentrate resources for an intense campaign of information and prevention on a global scale.
Vertebral Type A fractures are compression fractures, in which the internal structure of the vertebral body collapses resulting in the fracture. (Magerl scale)
Compression fractures of type A.1 (in which the continuity of the walls of the vertebra is guaranteed) are treated with a vertebroplasty operation which consists in the percutaneous insertion of a needle inside the fractured vertebra through its pedicle.
Once the needle has been positioned, PMMA is injected into the vertebra with the aim of consolidating the fracture and avoiding new sagging.Since the main cause of vertebral fractures is osteoporosis, in which the trabecular structure of the bone is very thin, followed by causes of an oncological nature, in which the vertebra has an internal osteolytic structure, a high viscosity PMMA is recommended for a treatment in total safety.
However, the use of high viscosity cements implies the use of hydraulic circuits for resin injection both to overcome the high resistances encountered and to ensure an application time sufficient to treat multiple levels.
VV+
Spinal Cement System
Spine surgeons today require ever more exacting standards for spinal bone cements such as; time reduction, leak avoidance and above all else: a genuine high viscosity radiopaque bone cement.
Axon has developed VV+® to meet these needs. VV+® is a unique high viscosity radiopaque bone cement, combined with a custom made High viscosity injection system designed to withstand high pressure injection.
VV+ Radiopaque Bone Cement
No more extra waiting time, HighV+® is ready to inject from the moment you start mixing, you can have up to 9 minutes of injection time at 20c (through a Gauge 11 or larger).
- Maximum visibility with unique radiopaque opacifier (Barium sulfate & 9% Hydroxyapatite)
- 10cc of HighV+
VV+ Mixing System
An intuitive Mixing system guarantees a homogenous blend thanks to its elliptique mixing blade.
- Designed to be easy to use, once the powder and liquid has been poured in, the system is transparent letting the user see the mixing process
- 100% contained, the user is never in contact with the cement
VV+ Injection System
The High Viscosity Injection System is an hydraulic injector, fillable with sterile water*
- A genuine high viscosity cement has high rheological properties and needs to be delivered at very high pressure. Only an hydraulic injector can manage this
- Easy to use high viscosity cement Injection system gives you total delivery control
How to use it
VV+ is a validated and FDA approved device. It is strictly forbidden to use othe devices that aren’t allowed.
Preparation
• Remove and place each component in a logical order.
• Fill the Chamber with sterile water*
Mixing phase
• The two components (powder and liquid) are to be mixed for 30 seconds.
Syringe filling
• Connect the syringe to the Mixing System output.
• Use the pusher to move the VV+® bone cement into the syringe.
• Install the filled syringe to the connector and prime it.
Injection phase (9 minutes)
• No waiting time is required, the cement is already pasty, ready to be injected safely.
• The pasty consistency corresponds to the level of viscosity required to prevent leakage.
• The VV+® Radiopaque Bone Cement has a very high viscosity, at 20°C, it can be used up to 9 minutes from the start of mixing.
• The cement injection must take place under continuous radiological guidance. When the operator
estimates that the vertebra is satisfactorily filled, then no more cement needs to be injected.
Certification:
VV+® Spinal Cement System is an assembly of 3 devices
VV+® Radiopaque
Bone Cement:
Classe IIb
High Viscosity
Injection System:
Classe: I steril
Mixing System Adapted
to High Viscosity injection System:
Classe: I steril
Project co-financed by the European Fund for Regional Development
Operational program ERDF CAMPANIA 2014-2020 Priority axis 3 – Action 3.1.1. public notice for support to MPMI Campania in the implementation of technology transfer and industrialization projects – SPINERY 2.0 PROJECT