AVAflex® vertebral balloon system
The AVAflex® vertebral balloon system combines confidence and precisionallowing bipedicular results to be achieved through a unipedicular approach¹,².With our multiple balloon sizes, you are able to tailor your treatment to yourpreferences and patient needs.
Features
• Less invasive offering3
• Smaller gauge size helps reduce soft tissue and/or bone trauma4
• Curved introducer with PEEK sheath protects the balloon and allows targeted balloon placement
• Directional markings to identify direction of curve
• Curved needle allows targeted cement delivery
• Depth markings to accurately place 15, 20, and 30mm balloons
• Available in 11G
AVAflex® vertebral balloon system – 11G
| 11G Balloon specifications | |||
| 15mm | 20mm | 30mm | |
| Volume | 3cc | 4cc | 6cc |
| Pressure | 400psi | 400psi | 400psi |
STEP BY STEP PROCEDURE
1) Insert the AVAflex® needle with the radiopaque introducer.
5) Inflate the AVAflex® vertebral balloon system.
2) Remove the AVAflex® needle, leaving the introducer in place.
6) Deflate the balloon. Remove the introducer and the deflated balloon simultaneously.
3) Place the AVAflex® vertebral balloon system down the introducer.
7) Prime the AVAflex® curved needle with bone cement and insert into the vertebral body. Fill the vertebral body with cement.
4) Expose the AVAflex® vertebral balloon system by retracting the introducer.
References
- Based on fill volume
- Chang W et al. Unilateral versus bilateral percutaneous kyphoplasty for osteoporotic vertebral compression fractures: A meta-analysis. Medicine (Baltimore). 2017; 96(17):e6738.
- As compared to bipedicular cases
- Nussbaum D et al. A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site. Journal of Vascular and Interventional Radiology. 2004; 15(11):1185-1192
Disclaimer
Bone cement: serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known occur beyond a year or more postoperatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.
2020-27613