Balloon kyphoplasty

Approach 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.

Are you experiencing one or more of these symptoms?¹²

Sharp, sudden back pain
Pain that increases during standing or walking
Pain that becomes less intense when lying on back
Pain that causes limited spinal mobility
Symptoms that do not improve with non-surgical treatment (bed rest, back brace and/or pain medications)

Procedure risks

Talk to your doctor

Many patients who undergo BKP are able to walk and return to normal activities soon after surgery.³ Conservative therapy for VCFs includes bed rest, pain medication, external back braces and physical therapy.¹ If there is little or no pain relief, your doctor may recommend vertebral augmentation.

What to expect with a balloon kyphoplasty procedure

View the procedure step-by-step

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.⁴ 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.⁵ The incision is covered with a bandage.

After the procedure

You’ll lie on your back for a short period of time while the cement continues to harden. Your vital signs will be monitored. Typically, patients are able to go home within a few hours of treatment.⁵ Please see the benefits and risks section of the brochure for more information.

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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.⁶⁷

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.⁸⁹¹⁰

Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.