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> > > KYPHONŽ HV-RŽ Bone Cement

KYPHONŽ HV-RŽ Bone Cement

KYPHONŽ HV-RŽ Bone Cement
General Information
VendorMedtronic (formerly Kyphon)
ItemKYPHONŽ HV-RŽ Bone Cement
Features
  • Ready for Use
    • Simply mix the monomer liquid and the polymer powder together in the KYPHONŽ Mixer. No other supplemental components are required.
  • Extended Working Time
    • Once KYPHONŽ HV-RŽ Bone Cement reaches optimal viscosity for Balloon Kyphoplasty, there are approximately 8 minutes of working time at 23ą1°C available. This allows increased time to fill the cavity.
  • Controlled Delivery
    • KYPHONŽ HV-RŽ Bone Cement can be delivered in the high-viscosity, doughy state under fine manual control through the KYPHONŽ Bone Filler Device.
  • High-Viscosity
    • KYPHONŽ HV-RŽ Bone Cement has a longer working time while in the high viscosity state, providing increased user control and ease of handling.
  • Radiopaque
    • KYPHONŽ HV-RŽ Bone Cement contains 30% Barium Sulfate. This eliminates the need to add supplementary radiopaque agents to the bone cement mixture.
  • Bone Cement KYPHONŽ HV-RŽ Bone Cement has sufficient loading capabilities for Balloon Kyphoplasty.
ApprovalUS FDA Class II Device 510K clearance
Product NumberContact customer center
ViscosityKYPHONŽ HV-RŽ Bone Cement has a longer working time while in the high viscosity state, providing increased user control and ease of handling.
Radiopaque?KYPHONŽ HV-RŽ Bone Cement contains 30% Barium Sulfate. This eliminates the need to add supplementary radiopaque agents to the bone cement mixture.
PricingInquire
Product Description
Indications:
The KYPHONŽ HV-RŽ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

Description:
KYPHONŽ HV-RŽ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for manual delivery in a highly viscous state.

Clinical study page: www.CompressionFractureStudy.com

Important Safety Information:MICHELSON TECHNOLOGY AT WORK
The complication rate with KYPHONŽ 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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