Anatomy and Prevalence of Vertebral Compression Fractures. The spinal column contains 24 bones called vertebrae. Each vertebra consists of a large block of bone, called the vertebral body, which helps maintain upright posture. The vertebral body consists of soft inner, or cancellous, bone surrounded by a thin outer shell of hard, or cortical, bone. The soft tissue between each vertebral body is generally referred to as the intervertebral disc. Each vertebra also has bone segments that extend out from the vertebral body, called the posterior elements, which surround and protect the spinal cord. Kyphoplasty and vertebroplasty treat compression fractures of the vertebral body, known as vertebral compression fractures. There are approximately 700,000 clinically diagnosed vertebral compression fractures in approximately 550,000 patients each year in North America, Europe and Japan due to osteoporosis. Osteoporosis is a disease that primarily affects women and men over the age of 50 and is characterized by bone deterioration that leads to an increased susceptibility to such fractures. These fractures can result in significant pain, reduced physical function and diminished quality of life. They can also result in a forward curvature of the spine, kyphosis, which can decrease lung function and is associated with an increased risk of death. Each year in North America, Europe and Japan, 150,000 fractures occur in 50,000 cancer patients due to the cancer or its treatments, also with debilitating consequences. Multiple myeloma, a cancer of blood cells that affects bone, and the spread of various cancers into bone, are the most common causes of spinal fracture due to cancer. Additionally, there are 100,000 patients per year in North America, Europe and Japan that suffer traumatic vertebral compression fractures which may be treatable with minimally invasive techniques similar to the treatments for fractures caused by osteoporosis and cancer.

Consequences of Vertebral Compression Fractures. When the spine is structurally weakened, routine downward pressure can cause a vertebral body to collapse and fracture. These fractures are referred to as vertebral compression fractures. Fractures of the vertebral body, located at the front of the spinal column, can cause the spine to tilt forward. Over time, these fractures can result in a curved deformity of the spine and a forward-stooped posture called kyphosis. Vertebral compression fractures are caused primarily by deterioration of the inner cancellous bone due to osteoporosis. Other causes of spinal fractures include trauma, cancerous and benign tumors and infection. Unrepaired spinal fractures can result in serious physical consequences, including:

•  Increased Risk of Mortality
•  Acute and Chronic Pain
•  Health Effects Resulting from Organ Compression
•  Functional Limitation
•  Increased Risk of Additional Fractures

Vertebral compression fractures are characterized by a loss of vertebral height and anatomical structure, which affects vertebral function and typically causes pain. These fractures, along with the pressure on the spinal cord caused by them, create pain as the compression pinches the nerve bundles that extend from the spinal cord. Vertebral compression fractures, one of the most common types of spinal fractures, are prevalent among patients affected by osteoporosis, such as the elderly, and post-menopausal women. Analysts suggest that approximately 700,000 spinal fractures occur per year in the United States. It is estimated that, worldwide, one in three women and one in eight men over the age of 50 are affected by osteoporosis, which predisposes the patient to an increased risk of fracture. According to the National Osteoporosis Foundation, 44 million people in the United States are at risk of osteoporosis, a quarter of whom already have the disease. Other causes of vertebral compression fractures include trauma, malignancy in the vertebrae and, more rarely, hemangioma, a condition which is characterized by benign tumors of blood vessels. An osteoporotic fracture can cause extreme back pain along with other symptoms, such as decreased height and spinal deformity. Chronic back pain is considered to be the most common cause of disability around the world and the second most common cause of missed workdays due to illness. In the United States alone, it is estimated by Frost & Sullivan that back problems cost the economy nearly $60 billion per year due to lost work, medical costs and rehabilitation. There are some non-invasive alternatives to aid healing and pain management for patients with vertebral compression fractures, including pain medication, dietary supplements, back braces, physiotherapy and exercise. However, these alternatives typically do not fully address the restoration of the anatomical integrity of the fracture and the related chronic back pain.