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INNOVATIONS THAT ADD UP

Discover how the OsteoCool™ RF ablation system and Kyphon™ balloon kyphoplasty procedure work together to address pain.
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OSTEOCOOL™ RF ABLATION

Advancing bone tumor ablation through clinical evidence. 

OpuS One Post-Market Study1: 100 Patients Treated with OsteoCool™ RF Ablation. The ongoing study demonstrates pain relief* that is:

  • Swift - 3 days post procedure 
  • Significant - improvement in worst pain
  • Sustained - through 6 months

KYPHON™ BALLOON KYPHOPLASTY

Unmatched commitment to the advancement of BKP therapy, and to thinking beyond the procedure.

  • Reliable - robust evidence supporting clinical results  
  • Flexible - procedural options to meet physician and patient needs 
  • Commitment - 20+ years of treating patients 
  • Standardization - with the VCF Care Pathway 
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Would you like to receive additional information on how OsteoCool™ RF Ablation and Kyphon™ Balloon Kyphoplasty are working together to address pain? 

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1

Levy J, Hopkins T, Morris J, et al. Abstract No. 346. Radiofrequency ablation for the palliative treatment of bone metastases: outcomes from a multicenter study in 100 patients. J Vasc Intervent Radiol. 2020;31(3 Supplement):S158. doi: https://doi.org/10.1016/j.jvir.2019.12.404.

*

Pre-ablation worst pain was 8.2 decreasing to 5.6 (n=94) at 3 days, 4.7 (n=89) at 1 week, 3.9 (n=64) at 1 month, 3.7 (n=46) at 3 months, and 3.5 (n=22) at 6 months. P<0.0001 all visits. 

IMPORTANT SAFETY INFORMATION

OSTEOCOOLTM RF ABLATION

INDICATIONS

  • Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. 
  • Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy. 
  • Ablation of benign bone tumors such as osteoid osteoma. 

RISKS

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could result 
  • Pulmonary embolism
  • Nerve injury including thermal injury, puncture of spinal cord or nerve roots potentially results in radiculopathy, paresis, and paralysis

KYPHONTM BALLOON KYPHOPLASTY

The complication rate with KyphonTM 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.

Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other serious adverse events such as:

  • Cardiac arrest
  • Cerebrovascular accident
  • Myocardial infarction
  • Pulmonary embolism
  • Cardiac embolism

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.