Confidence Spinal Cement System®

The CONFIDENCE SPINAL CEMENT SYSTEM® combines a highly viscous cement with a hydraulic delivery system. The radiopaque cement achieves high viscosity immediately post-mixing and has predictable and reliable cement viscosity. The hydraulic delivery system enables a smooth introduction of highly viscous cement into the vertebral body.

The CONFIDENCE System is part of a complete procedure solution for the personalized treatment of vertebral compression fractures. CONFIDENCE SYSTEM is supplied sterile. The a la carte offering allows for maximum economy, flexibility and precise surgical planning.

CONFIDENCE HERO

Features & Benefits

CONFIDENCE FEATURES AND BENEFITS #3

Highly Viscous Cement

  • Cement that achieves high viscosity immediately post-mixing

Predictable and Reliable

  • Cement viscosity for 8-10 minutes of working time (at a standard OR temperature of 68°F/20°C)

Hydraulic Remote Delivery

  • Streamlined setup with simple mixing and transfer tools
  • A hydraulic-based delivery system that allows for a controlled flow of cement
  • Remote cement delivery to minimize physician exposure to radiation

References

No available references for this product.

Indication Statement

The CONFIDENCE SPINAL CEMENT SYSTEM® –11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is 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). The CONFIDENCE High Viscosity Spinal Cement may also be used in conjuction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, including VERSE®. For Indications, Contraindications, Warnings and Precautions associated with this use, please reference the appropriate Fenestrated Screw System Instructions for Use.

Contraindications

The use of CONFIDENCE 11cc High Viscosity Spinal Cement is contraindicated in patients presenting with any of the following conditions:

• Use of CONFIDENCE 11cc 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 11cc High Viscosity Spinal Cement.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information. Refer to the package inserts for complete system descriptions, indications, contraindications and warnings.

128055-191120 DSUS