Category: Vertebral Body Augmentation / Kyphoplasty
The CONFIDENCE SPINAL CEMENT SYSTEM® combines unique highly viscous cement with a novel hydraulic delivery system. The radiopaque CONFIDENCE System reaches a dough-like phase immediately after the cement components have been mixed, without going through a liquid phase. The hydraulic delivery system enables a smooth introduction of the highly viscous cement into the vertebral body.
The CONFIDENCE System is part of a complete procedural solution for the personalized treatment of vertebral compression fractures. The a la carte offering allows for maximum economy, flexibility and precise surgical planning.
The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE 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 use of Confidence Spinal Cement is contraindicated in patients presenting with any of the following conditions:
WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.
CAUTION: USA law restricts this device to sale by or on the order of physician.
|High viscosity cement||Reduced risk of extravasation|
|Hydraulic based delivery system||Controlled flow of highly viscous cement through a small gauge introducer needle|
|Remote delivery system||Reduced radiation exposure|
|Ready to use upon mixing||Decreased OR time and stress around timing the mix|
|10G, 11G, 13G or 15G introducer needles||Access through large and small pedicles throughout the spine|