Xpede Clinical Study

Exclusion Criteria

• •1. Subject has a local or systemic infection.
• •2. Subject has pains caused by other spine disease than painful pathological vertebral compression fracture.
• •3. Subject has a medical condition with less than 1 year of life expectancy.
• •4. Subject is grossly obese, i.e. BMI≥40.
• •5. Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision.
• •6. Subject has an allergy or an intolerance to bone cement component.
• •7. Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable.
• •8. Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor.
• •9. Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence.
• •11. Subjects with medical condition which precludes them from participation in the opinion of the Investigator.