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FDA grants marketing clearance to bone cement
SUNNYVALE, Calif. — Kyphon Inc. announced that it has received 510(k) clearance from the Food and Drug Administration to market KyphX HV-R Bone Cement for the fixation of osteoporosis-related pathological fractures of the vertebral body during kyphoplasty.
“This clearance is a significant event in the evolution of balloon kyphoplasty as a treatment option for patients with spinal fractures related to osteoporosis,” Richard Mott, president and chief executive officer of Kyphon, said in a press release. “By launching our KyphX HV-R Bone Cement in the United States, we will be able to provide and promote a complete procedural solution for surgeons who treat patients with these fractures. In addition, we can now train spine specialists on appropriate techniques for delivering bone cement during balloon kyphoplasty.”
Kyphon’s proprietary KyphX HV-R (high viscosity-radiopaque) polymethylmethacrylate bone cement is designed to have the desired handling and visualization characteristics for minimally invasive spine surgery. The cement has been cleared for treating vertebral fractures caused by osteoporosis using kyphoplasty.
“Our KyphX HV-R Bone Cement is the first material specifically indicated for the treatment of osteoporotic fractures and will further Kyphon’s position as a leading innovator in minimally invasive spinal fracture therapies,” Mott said in the release.
The company anticipates a second-quarter, full U.S. market release.
Balloon kyphoplasty is a minimally invasive spinal surgery that has been demonstrated to achieve sustained vertebral body height restoration and angular deformity correction in patients with vertebral body compression fractures caused by osteoporosis, according to the company.
Substantial equivalence was determined based on clinical data provided in the 510(k) demonstrating that the procedure is associated with significant and maintained reduction in back pain, improvement in quality of life, and an increase in the ability to perform activities of daily living and patient mobility. As with most surgical procedures, there are risks associated with kyphoplasty, including serious complications, although the complication rate with kyphoplasty has been demonstrated to be low, according to the release.