Kyphon receives FDA clearance to market KyphX HV-R Bone Cement for use in kyphoplasty

Sunnyvale 05 April 2004Kyphon Inc. has received 510(k) clearance from the Food and Drug Administration (FDA) to market KyphX HV-R Bone Cement for the fixation of osteoporosis-related pathological fractures of the vertebral body during kyphoplasty. The finding of substantial equivalence was based on clinical data supporting certain short and long term outcomes of kyphoplasty.

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"This clearance is a significant event in the evolution of balloon kyphoplasty as a treatment option for patients with spinal fractures related to osteoporosis", commented Richard Mott, President and Chief Executive Officer of Kyphon. "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. Further, we believe clearance to promote the cleared clinical outcomes of kyphoplasty to the referring physician community and among patients and caregivers will enhance our ability to penetrate our core market over the long term", added Richard Mott.

Kyphon's proprietary KyphX HV-R (High Viscosity - Radiopaque) polymethylmethacrylate (PMMA) Bone Cement is designed to have the desired handling and visualization characteristics for minimally invasive surgery in the spine. The cleared indication for use is for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure. The company is initiating launch activities in preparation of an anticipated second quarter full United States market release.

"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 an innovator in minimally invasive spinal fracture therapies", concluded Richard Mott.

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. 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 increase in 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. Kyphon develops and markets medical devices designed to restore spinal function using minimally invasive technology. The company's initial products are used in balloon kyphoplasty, a minimally invasive procedure to treat spinal fractures caused by osteoporosis.


Leslie Versweyveld

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