Indications:
The KYPHON® ActivOs™10 Bone Cement with Hydroxyapatite 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:
KYPHON® ActivOs™ 10 Bone Cement with Hydroxyapatite contains 10% hydroxyapatite by weight in the powder. KYPHON® ActivOs™ 10 Bone Cement has been shown in an animal trial to provide direct bony apposition on the surface of the cement without any intervening fibrous tissue layer when implanted into rabbit femurs (n=8) and 2 rabbits were harvested at each 1, 6, 9 and 12 month time point. Stained histological sections showed new bone formation on the cement surface. This phenomenon has not been assessed in clinical trial and may not be predictive of clinical experience. The addition of HA has not been shown to provide any improved clinical benefits.
Clinical study page:
www.CompressionFractureStudy.com
Important Safety Information: 
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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