Bone cement, vertebroplasty and kyphoplasty sets

7 June 2020

Vertebroplasty also called vertebral consolidation or percutaneous spinal stabilization is a minimally invasive procedure in which the vertebra is strengthened and stabilized by direct injection of bone cement for spinal stabilization under fluoroscopic observation.

With successful surgery, vertebroplasty restores the patient's movement ability and reduces the risk of new fractures to a previously treated trauma. The G21 vertebroplasty provides an optimal recovery period for the patient and is fully covered by the Bulgarian National Health Insurance Fund.

Vertebroplasty is also used in more specific pathological conditions, such as osteoporosis and metastases, which can weaken the vertebrae to such an extent that they break as a result of stress from normal life activities.

The G21 vertebroplasty kit provided by Helmed Bulgaria Ltd. consists of:

- V-FIX bone cement

- PicoMix V mixing system: mixer, 4 syringes, spatula and funnel

- V-ACCESS Bone Cement Injection Needle/cannula (11G or 13G)

- V-HP GUN gun for injection of bone cement under high-pressure

G21 bone cement V-FIX is used to stabilize the spine in fractures and injuries, as well as in other pathological conditions, such as osteoporosis or tumors. Bone cement allows for minimally invasive surgery and provides an optimal level of safety, visibility, and control for the practitioner during the procedure.

The V-FIX formula facilitates the fusion of biomaterial and bone structure, eliminating the risk of leakage and other complications. The product is suitable for extremely delicate procedures that require some time before polymerization - for example, to perform surgery on several parts of the spine.

The patient's advantages include a short recovery period and a reduced risk of thermal shock to the tissues due to the low polymerization temperature. Also, the need for painkillers is significantly reduced after the procedure.

Advantages of V-FIX bone cement:

- Low viscosity Long working time (9-11 minutes)

- Low polymerization temperature - 65 °

- X-ray negative

Another innovative method for spinal stabilization is kyphoplasty.

Kyphoplasty, like vertebroplasty, is a minimally invasive percutaneous intervention. The difference between them is that while vertebroplasty is only for stabilization, treatment of symptoms and pain relief, kyphoplasty can restore and correct spine height as a result of vertebral deformity, osteoporotic compression fractures and other.

During the procedure, a catheter with a balloon tip is placed in the damaged area of the spine. Through a small cannula, a fluid containing a contrast medium is poured into the balloon, which contributes to the restoration of the natural position and height of the damaged spine. After removal of the balloon, the same cannula is used for the injection of bone cement into the resulting space, which will eventually stabilize and correct the deformation.

Benefits of G21 kyphoplasty:

- Reduced risk of complications during and after the intervention

- Restores the height of the vertebrae and the correct shape of the spine

- It is partially reimbursed by the NHIF

The G21 medical devices meet the European quality requirements and hold all the necessary certificates:

- ISO 13485: 2012 certificate

- EC Certificate (Class IIb and III)

- CE (0476)

The Italian company G21 is a manufacturer of bone cement, vertebroplasty and kyphoplasty kits.

G21 is a proven European manufacturer and a world leader in invasive neurosurgical medical devices.

Helmed Bulgaria is the exclusive representative, importer, and distributor of the products of the Italian company G21.

Contact us for more information and details on G21 products!