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SKy Bone Expander System for International Residents (non-US)


The SKy Bone Expander is a polymer device, intended for kyphoplasty. The SKy Bone Expander is inserted into the collapsed vertebra in a reduced device configuration of 4 mm in diameter. Once positioned within the vertebra, it is expanded to up to 14 mm or 16 mm in height and its pre-designed expanded size in a controlled manner. Once optimal vertebra height and void are achieved, the SKy Bone Expander is removed and void filler is injected into the void.

FEATURES

*Creates a defined void in a controlled manner.

*Provides maximal user control over the extent of device expansion.

*Gradual expansion to pre-defined configuration avoids breaching of the vertebral walls.

*Increases vertebral height.

*Assures safe and localized injection of bone filler in the void.

*Enables percutaneous approach.

*Available in different sizes.


PRINCIPLES OF OPERATION

*The SKy Bone Expander is inserted percutaneously into the collapsed vertebra.

*The physician can control the placement and extent of SKy expansion.

*Controlled manual SKy expansion results in void creation and vertebral body reconstruction.

*The SKy is manually contracted and withdrawn from the vertebra.

*The created void is then filled with cement or bone filler material.

*The result is a reconstructed, strengthened vertebra.

INDICATION

The SKy Bone Expander System is intended for use in the treatment of thoracic and lumbar spine vertebral body compression fractures at levels T5-L5.

Not available in the USA

2006-07-01 05:03:59 · answer #1 · answered by realove336 5 · 0 0

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