High viscosity Injection System + Mixing System + Radiopaque Bone Cement
Today, 30% of women over age 50 are victims of fracture caused by osteoporosis.
Half of these osteoporotic fractures involve the spine and result in vertebral fractures.
To treat these fractures, there is a technique: vertebroplasty. The main complication encountered during vertebroplasty is asymptomatic cement leakage during the gesture.
In order to reduce these leaks, the indicated cements for vertebroplasty have evolved to become more viscous.The rheological properties of these cements require the use of a new type of mixing systems and injection.
The HighV+® Spinal Cement System have been specially developed for the range of ultra high viscosity cement.
HighV+® Spinal Cement System is composed of:
- One dose of HighV+® Radiopaque Bone Cement.
- One Mixing System which allows obtaining a perfect mixture of cement.
- A High Viscosity Injection System in order to inject easily the HighV+® Radiopaque Bone Cement
- Ultra Strong
- Reduced radiation exposure.
- Ultra high viscosity system
- Homogeneous mixture by epicyclical movement
- Ready to use
- Easy transfer
- Smooth injection
The maximum temperature of 56°C is reached during the polymerisation of High V+ and lies well below that required by the ISO 5833 Standard, thus reducing the danger of bone necrosis.
Unlike low and medium viscosity cements whose initial viscosities are 10 and 100 Pa.s respectively, High V+ has a very high viscosity (around 1300 Pa.s.) immediately after mixing. The risks of cement leakage, a very frequent risk in vertebroplasty and kyphoplasty, are thus greatly reduced.
Once the initial high viscosity of the HIGH V+ cement has been reached, there is still sufficient injection time to conduct the procedure in absolute safety. Patient comfort, as well as that of the surgeon, is thus greatly improved.
The physical properties of High V+ cement largely exceed the requirements of the ISO 5833 Standard.
Properties of High viscosity injection system:
The High Viscosity Injection System is a hydraulic injector.
In view of the rheological properties of cement High V+® very important, it is necessary to have the most efficient system possible. The transmission of force by hydraulic energy is the most interesting, the High Viscosity Injection System uses this concept.
Nowadays, most of the surgeries are performed under X-rays, it requires having a control away from the surgical site so that the surgeon works safely. The High Viscosity Injection System therefore has two parts: a control part and an injection part connected by a hydraulic line.
The High Viscosity Injection System assures optimally controlled and safe injection until 8cc into the vertebral body.
Properties of Mixing system:
The Mixing System is a device who permits to have a mixture homogeneous of the cement High V+® quickly thanks to the planetary motion of his mixing blade.
The design of the Mixing System guarantees an ease of implementation. The powder and the liquid is introduced no problem in the device.
A visualization of the mixing step is performed by the transparent appearance of the walls of the mixer. Moreover, the use of High Viscosity Mixing System is very reproducible. The surgeon never is in contact with cement that allows a job security.
In order to achieve the transfer of the mixed cement, the output of the mixer is adapted to the syringe of the injection part.
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|HighV+® Spinal Cement System
Class : I Sterile