INDICATIONS FOR USE
The CONFIDENCE SPINAL CEMENT SYSTEM™ is intended for percutaneous delivery of CONFIDENCE Spinal Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

CONTRAINDICATIONS
The use of CONFIDENCE High Viscosity Spinal Cement is contraindicated in patients presenting with any of the following conditions:

• Use of CONFIDENCE High Viscosity Spinal Cement for prophylaxis (such as in metastatic or osteoporotic patients with no evidence of acute vertebral fracture)
• Coagulation disorders, or severe cardiopulmonary disease.
• Haemorrhagic diasthesis.
• Non-pathological, acute, traumatic fractures of the vertebra.
• Patient clearly improving on medical therapy.
• Spinal stenosis (> 20% by retropulsed fragments).
• Compromise of the vertebral body or walls of the pedicles.
• Compromise or instability of vertebral fractures due to posterior involvement.
• Anatomical damage of the vertebra that prevents safe access of the needle to the vertebral body.
• Vertebral body collapse to less than 1/3 (33%) original height.
• Vertebral plana (collapse >90%)
• Active or incompletely treated infection.
• Coagulopathy or inability to reverse anti- coagulant therapy (both during and approximately 24 hours post-procedure).
• Severe pulmonary insufficiency.
• Allergic reaction to any of the components of the CONFIDENCE High Viscosity Spinal Cement.