According to the most recent statistics from the National Osteoporosis Foundation, more than 750,000 osteoporotic compression fractures of the spine occur in the U.S. annually. Although the majority of vertebral compression fractures (VCFs) are asymptomatic, it is estimated that nearly one-third become chronically painful, resulting in more than 250,000 hospitalizations per year. VCFs are a leading cause of disability and morbidity in the elderly population, since older patients with collapsed vertebrae due to primary or secondary osteoporosis have an impaired ability to heal. Consequently, even in the absence of pain, the result can be severe spinal deformity (kyphosis), which can lead to a deterioration of physical function if left untreated.
The treatment of VCFs has evolved into a $375 million per year industry in the U.S. (almost $500 million worldwide), controlled primarily by one company: Kyphon Inc.(Sunnyvale, CA). As shown in Figure 1, Kyphon’s devices were used to treat about 115,000 VCFs in 2006, the vast majority due to osteoporosis
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