Until now, most spine surgeons wouldn't even treat osteoporotic fractures of the spine, referring such patients to medical management. But using technology borrowed from balloon angioplasty, Kyphon has developed instrumentation that represents a new clinical approach to this serious problem. As with most device companies, regulatory issues and reimbursement have been a challenge, as have comparisons with another spinal procedure, vertebroplasty.

The spinal orthopedics business, long focused on traditional fixation tools such as screws, dowels, cements, and more recently, interbody fusion cages, has been undergoing a slow evolution that also incorporates a biological approach to bone healing. Orthovita believes its glass/resin-based bioactive materials mimic the biology of bone healing better than previous synthetics, and that these materials can more easily incorporate biologic agents for an added bone-healing boost. Now the company faces the challenge of generating the data that will differentiate it from a host of competitors making similar claims and enable it to penetrate a market inherently slow to adopt new technology.

With the increasing popularity of vertebroplasty, a minimally invasive procedure for treating vertebral compression fractures, reports of multiple deaths--apparently due to leakage of bone cement from the vertebral body through the veins and into the CV system and lungs--are beginning to surface.