Vertebral consolidation – Kyphoplasty

Osteoporotic vertebral fractures are usually compression fractures that result in a loss of vertebral body height. These fractures sometimes need to be stabilized, and, in many cases, they can be treated without open surgery, using interventional radiology procedures.
Spine reinforcement with vertebroplasty or kyphoplasty is part of the recommended treatments for symptomatic vertebral fractures.
The main goal of these procedures is the treatment of pain and secondary deformities. Balloon kyphoplasty is intended alleviate pain, stabilize the fracture and restore the loss of height of the vertebral body, correcting and preventing the progression of the kyphotic deformity.
The procedure involves the insertion of one or two inflatable bone buffers (balls) in the vertebrae. Once inflated, the ball creates a cavity, filled with bone cement. It is believed that the creation of this cavity decreases the risk of loss of cement. The effect of the balloon is to create a cavity compressing the trabeculae that provides a solid front capable of moving the vertebral plate.
Fluoroscopy permits direct control of the injection, thanks to the G21 bone cements for vertebral consolidation containing a contrast agent (Barium sulphate for V-FIX and Zirconium oxide for V-FAST and V-STEADY) that makes they visible.

The Winch Kyphoplasty Balloon Catheter device is a single-use, coaxial lumen catheter with a balloon placed at the distal tip.
After an initial step of creating access and working cavities, and subsequent placement of the device in the vertebral body, the balloon is inflated, compressing the spongy bone present within the vertebral body and displacing the cortical bone.
This procedure restores the height of the vertebral body, creating a cavity that, once the balloon is removed, deflated, will go to be filled with bone cement, to consolidate its height.
Radiopaque markers are engraved on the inner stem of the balloon, located at the proximal and distal ends of the balloon, allowing fluoroscopic visualization during its placement.
Available in 15 mm and 20 mm lengths. Smaller diameter allows for accurate placement in small vertebral bodies and upper thoracic levels.
Lower pre-inflation profile enables insertion into smaller working cannula (3 mm diameter). Maximum inflation volume: 4 cc.

HOW TO ORDER

The kit includes the instruments (in the small-gauge versions) necessary for performing one kyphoplasty procedure with the direct access method. Integrated, one-step design for quick and efficient percutaneous access to the bone and creation of the channel. No instruments exchange and smaller diameter system allow to effectively reduce the trauma.

The two versions available differ in the size of the balloon included, so that the operator can choose the one most suitable for each individual patient. Direct access needle is available with “bevel” or “trocar” tips to suit physician preference, customizing the treatment approach.

HOW TO ORDER

Il KEYFIX™ Traditional Access is a conversion kit to be used for traditional acces kyphoplasty procedures; it is composed by:

• Kirschner guide wire (nr. 2 pc);
• First access needle (13G) with trocar tip (nr. 1 pc);
• Working cannula (nr. 1 pc).

HOW TO ORDER

The KEYFIX™ Bone cement filler cannula (diameter 1,7 mm) is used for the pedicle screw cementation.

HOW TO ORDER

Biopsy KIT With 5-ml syringe and sampling tube.

HOW TO ORDER

A flexible drill made of medical grade nitinol that can be used to create a cavity suitable for the kyphoplasty balloon catheter in the vertebra.

HOW TO ORDER