Balloon kyphoplasty | Interventional Spine
Balloon kyphoplasty
Approach fracture-associated back pain with a minimally invasive solution
The balloon kyphoplasty (BKP) procedure has been reported to provide patients with significant improvements in pain, mobility and the ability to perform daily tasks.1,2
Treating spine fractures can save lives
A study of over 2 million Medicare VCF patients showed that only 15 patients need to be treated with vertebral augmentation to save a life at one year compared to nonsurgical management.10
How it works
Before the procedure
Your doctor will do a physical exam and order x-rays and/or other imaging tests, such as an MRI, CT or bone scan.11 These tests help to determine the location of the fractured vertebra, how recently the fracture occurred and whether or not vertebral augmentation with BKP is the most appropriate treatment.
During the procedure
Generally, vertebral augmentation with BKP is performed while you are awake but sedated. Your back is numbed by a local anesthetic. Using x-ray guidance, a balloon is inserted into the fractured vertebra through a small incision. The balloon is then inflated, creating a void or cavity. Once the void is established, the balloon is deflated and removed. The void is then filled with bone cement to stabilize the fracture. As it hardens, the cement forms an internal cast that holds the vertebra in place.12 The incision is typically covered with a bandage.
After the procedure
Your vital signs will be monitored. Typically, patients are able to go home within a few hours of treatment.12 Please see the benefits and risks section for more information.
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Resources
Potential risks of the procedure
Serious side effects have been known to occur with the use of bone cement in surgical procedures of the spine. These include heart attack, cardiac arrest (heart stops beating), stroke, embolism (blood clot or bone cement that moves to the heart or lungs) or death. Side effects may occur beyond a year or more after the procedure.13,14
Side effects related to use of an inflatable balloon system with bone cement include wound infection, bleeding, hematoma (collection of blood outside a blood vessel), pneumothorax (collapsed lung) and anaphylaxis (severe, life-threatening allergic reaction) due to rupture of the balloon.
Please consult with your doctor for the full list of possible side effects related to the combined use of bone cement with the iVAS and iVAS Elite inflatable vertebral augmentation systems and the OmniCurve curved balloon system.15-17
*Within 7 days post-treatment
†Observed through the 24‑month follow‑up period
The information presented is for educational purposes only. Stryker is not dispensing medical advice. Please speak to your doctor to decide what course of treatment is right for you. Only your doctor can make the medical judgment regarding which products and treatment is right for you. Any medical procedure carries certain risks and your doctor will explain all possible complications and/or side effects. Not all patients will experience the same results.
Stryker or its affiliated entities own, use or have applied for the following trademarks or service marks: AutoPlex, Dekompressor, Discmonitor, iVAS, mild, MultiGen, OmniCurve, OptaBlate, PCD, SpinePlex, SpineJack, Stryker, Venom, VertaPlex, VertaPlex HV, Verteport, and Verteport X4 Manifold. All other trademarks are trademarks of their respective owners or holders.
- Edidin A et al. Life expectancy following diagnosis of a vertebral compression fracture. Osteoporosis International. 2013; 24(2):451-458
- Siemionow K, Lieberman IH. Vertebral Augmentation in Osteoporotic and Osteolytic Fractures. Curr Opin Support Palliat Care. 2009 Sep;3(3):219-25
- Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and Safety of Balloon Kyphoplasty Compared with Non-surgical Care for
Vertebral Compression Fracture (FREE): a Randomized Controlled Trial. Lancet. 2009 Mar 21;373(9668):1016-24. - Passias PG, Li Gang, Wood, KB. SRS Position Paper: The Results of Vertebral Augmentation Procedures. Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School
Boston, MA. Sept. 8, 2008. - Garfin SR, Buckley RA, Ledlie J; Balloon Kyphoplasty Outcomes Group. Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine. 2006 Sep 1;31(19):221320].
- Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of "kyphoplasty" in the treatment of painful osteoporotic vertebral compression fractures. Spine. 2001 Jul 15;26(14):1631-8.
- Taylor RS, Fritzell P, Taylor RJ. Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta- analysis. Eur Spine J. 2007 Aug;16(8):1085-100. Epub 2007
Feb 3. - Taylor RS, Taylor RJ, Fritzell P. Ballon kyphoplasty and vertebroplasty for vertebral compression fractures: A comparative systematic review of efficacy and safety. Spine. 2006 Nov 1;31(23):2747-55
- Yu, C. W., Hsieh, M. K., Chen, L. H., Niu, C. C., Fu, T. S., Lai, P. L., Chen, W. J., Chen, W. C., & Lu, M. L. (2014). Percutaneous balloon kyphoplasty for the treatment of vertebral compression fractures. BMC surgery, 14, 3. https://doi.org/10.1186/1471-2482-14-3
- Hirsch J et al. Number needed to treat with vertebral augmentation to save a life. American Journal of Neuroradiology. 2020; 41(1):178-182.
- Wong C and McGirt M. Vertebral compression fractures: A review of current management and multimodal therapy. Journal of Multidisciplinary Healthcare. 2013; 6:205-214.
- Levin R. (2018, October 17). Kyphoplasty procedure overview. Retrieved June 2, 2025 from: https://www.spine-health.com/treatment/back-surgery/kyphoplasty-procedure-overview
- VertaPlex IFU (0406-422-715 Rev-E)
- VertaPlex HV IFU (0406-622-715 Rev-AB)
- iVAS IFU for 8G, 10G & 11G balloons (0705-215-700 Rev-AA)
- iVAS IFU for 13G balloons (1021-310-700 Rev-AA)
- OmniCurve IFU (700001140390 Rev-AD)
IVS-OMNI-MICRO-1695808_REV-0