SYNFLATE® Vertebral Balloon System
The SYNFLATE® Vertebral Balloon System provides a low profile 10 G access and streamlined balloon preparation technique. The system also provides multiple needle tip and cement delivery options as well as a simple, easy-to-use inflation device.
SYNFLATE® Vertebral Balloon is part of a complete procedure solution for the personalized treatment of vertebral compression fractures. The SYNFLATE® Vertebral Balloon is supplied sterile. The access instruments are supplied sterile and packaged separately. An a la carte offering allows for maximum economy, flexibility and precise surgical planning.
Available in three sizes:
The SYNFLATE® Vertebral Balloon available in Small (10mm), Medium (15mm), and Large (20mm) to fit varying patient anatomy.
Double lumen catheter:
Double lumen catheter: Outer lumen for inflation and Inner Lumen for optional stiffening wire
Two Radiopaque markers:
Two Radiopaque markers inside the balloon catheter to facilitate accurate placement of the balloon through X-Ray visualization
Marker bands on the catheter shaft that corresponds to the balloon length and helps identify proper advancement in working cannula and vertebral body
The SYNFLATE Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.