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> > > KYPHON Xpander™ Inflatable Bone Tamp (IBT) for Balloon Kyphoplasty

KYPHON Xpander™ Inflatable Bone Tamp (IBT) for Balloon Kyphoplasty

KYPHON Xpander™ Inflatable Bone Tamp (IBT) for Balloon Kyphoplasty
General Information
VendorMedtronic (formerly Kyphon)
ItemKYPHON Xpander™ Inflatable Bone Tamp (IBT) for Balloon Kyphoplasty
Features
  • Low pre-inflation profile allows for accurate placement inside the vertebral body through a cannula.
  • Radiopaque markers allow for accurate visualization of balloon during positioning prior to inflation with contrast medium.
  • An exit marker band on the IBT shaft indicates when the balloon is at the distal tip of the cannula.
  • A color-coded band on the shaft indicates balloon length.
  • Easy Prep Valve allows for simple and easy balloon preparation.
ApprovalUS FDA Class II Device 510K clearance
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Product Description
Indications:
KYPHON Xpander™ Inflatable Bone Tamps (IBT) are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

Description:
The working surface of the IBT is designed to compress cancellous bone and/or move cortical bone as it inflates.

Clinical study page: www.CompressionFractureStudy.com

Important Safety Information: MICHELSON TECHNOLOGY AT WORK
The complication rate with KYPHON® Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use included with the product.

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