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Kyphoplasty Balloon Dilatation Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).

The proposed device, Kyphoplasty Balloon Dilatation Catheters are inflatable balloon catheters used in percutaneous kyphoplasty (PKP). It consists of Inner Stylet, Balloon Catheter, and polypropylene (PP) Protection tube. The radiopaque markers located at the balloon catheter tip to reflect the balloon position during positioning.

The proposed device, Kyphoplasty Balloon Dilatation Catheters are inflatable balloon catheters used in percutaneous kyphoplasty (PKP). It consists of Inner Stylet, Balloon Catheter, and polypropylene (PP) Protection tube. The device is made of PC, stainless steel, TPU, PE, Pebax and Pt/Ir.

The inner stylet is made from a stylet attached to a 6% Luer cap. The stylet enhances the stiffness of the balloon catheter to facilitate a smooth insertion of balloon catheter through the established working pathway during the percutaneous procedure. The PP Protection tube protects the balloon from damage during the production and packaging.

The balloon catheter is composed of six sections: Inflation Port, Stylet Port, Inner Tube, Outer Tube, Radiopaque Markers, Inflatable Component. The Stylet Port is used to provide a support for the Stylet. The Inflation Port provide an adapter for a balloon inflation Injector. The Inflatable Component plays a critical role in the procedure. The Inflatable Component is to restore the height of a compression-fractured vertebral body and also leave a cavity in the fractured area after the Inflatable Component deflation. The cavity is therefore to facilitate safer filling of the bone cement. The cavity in the fractured area left by the inflated balloon reduces the filling pressure of bone cement. This technology greatly reduces the risk of uncontrollable bone cement leakage and spread, and thus lowers complications and minimizes the risk of the procedure.

The radiopaque markers located at the balloon catheter tip to reflect the balloon position during positioning.

Kyphoplasty Balloon Dilatation Catheters are supplied sterilized, single-use.

There are generally two types of Kyphoplasty Balloon Dilatation Catheters, one is straight type which has a straight balloon catheter tip, and the other one is curved type which has a curved shape of tip of the balloon catheter. These catheters are available in different effective length. The detailed specifications are listed in Table 1.

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