About KYPHON® Balloon Kyphoplasty
KYPHON® Balloon Kyphoplasty (BKP) is a minimally invasive surgical procedure indicated for treatment of painful vertebral compression fractures (VCFs) caused by osteoporosis, cancer or benign lesions. The therapy aims to reduce and stabilize the fracture, thereby providing immediate and sustained pain relief, improved physical function and better quality of life 3,4,5,6
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KYPHON® BKP is a percutaneous procedure that involves use of access tools with inflatable bone tamps placed inside the affected vertebral body. Balloon inflation compacts the cancellous bone and pushes the endplates apart. Once the balloons have been removed, the resulting void is filled with viscous bone cement to stabilize the vertebral body. By contrast, vertebroplasty involves insertion of a catheter and injection of liquid cement into the body without creating a cavity for the cement.4,5
The KYPHON Express II Inflatable Bone Tamp is the newest addition to the portfolio which already includes KYPHON Express(TM), KYPHON Xpander(TM) and KYPHON Xpander(TM) II.
The KYPHON Xpander(TM) II Inflatable Bone Tamps and KYPHON Express(TM) II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
The complication rate for KYPHON® Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure, including serious complications, and though rare, some of which may be fatal. These include, but are not limited to heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood, fat or cement that migrates to the lungs, heart, or brain). Other complications include infection and leakage of bone cement into the muscle and tissue. Cement leakage into the blood vessels may result in damage to the blood vessels, lungs, heart, and/or brain. Cement leakage into the area surrounding the spinal cord may result in nerve injury that can, in rare instances, cause paralysis. A prescription is required. Please consult your physician for a complete list of indications, contraindications, benefits, and risks. Only you and your physician can determine whether this procedure is right for you.
KYPHON Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.
