Category: Vertebral Body Augmentation (inc Vertebroplasty, Kyphoplasty, Stentoplasty)
The CONFIDENCE® SPINAL CEMENT SYSTEM® combines unique highly viscous cement with a novel hydraulic delivery system. The radiopaque CONFIDENCE® High Viscosity Cement reaches a dough-like phase immediately after the cement components have been mixed, without going through a liquid phase. In addition, the viscosity of the CONFIDENCE® Cement remains relatively constant throughout the entire working time of 8–10 minutes (at a standard OR temperatures of 68F/20C). The hydraulic delivery system enables a smooth introduction of this highly viscous cement through a specially designed 10G, 11G, 13G or 15G introducer needle.
CONTROL THROUGH VISCOSITY:
High Viscosity Without the Wait
– The CONFIDENCE® High Viscosity Spinal Cement provides immediate post mixing high viscosity with optimal working time when compared to a major competitor.
CONTROL THROUGH DELIVERY:
– Hydraulic based delivery system allows for a controlled flow of highly viscous cement through a small gauge introducer needle.
CONTROL THROUGH SIMPLICITY:
– Novel mixing and transfer tools allow for simple streamlined set up.
– Seamless mixing and transfer in one bowl
– Contained cement transfer designed to limit vapours
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 (haemangioma), and malignant lesions (metastatic cancer, myeloma).
The use of CONFIDENCE® High Viscosity Spinal Cement is contraindicated in patients presenting with any of the following conditions:
Limited Warranty and Disclaimer:
DePuy Synthes Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.
In the USA, this product has labelling limitations. See package insert for complete information.
USA Law restricts these devices to sale by or on the order of a physician.
|High viscosity cement with decreased risk of cement leakage||
|Hydraulic based delivery system||