KYPHON ActivOs 10 Bone Cement with HA launched to treat patients with VCFs

Medtronic, Inc. (NYSE:MDT) today announced the launch of KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON^® Balloon Kyphoplasty.

“The cement has great handling characteristics, is highly radiopaque and has optimal working time for clinicians to complete the balloon kyphoplasty procedure. I feel comfortable in using it on my patients with spinal fractures caused by cancer or osteoporosis.”

The launch of KYPHON ActivOs 10 Bone Cement with Hydroxyapatite in the United States marks a milestone for the Kyphon Products Division, part of the Spinal and Biologics business at Medtronic. With this product, Medtronic now has a portfolio of cements offering surgeons a choice for treating VCF patients. Surgeons performing KYPHON Balloon Kyphoplasty can now use either KYPHON HV-R^® Bone Cement, a PMMA bone cement, or KYPHON ActivOs 10 Bone Cement with Hydroxyapatite, a PMMA-HA composite bone cement.

HA is chemically and structurally similar to the mineral component of bone, has been widely studied¹, and has a long history of use in dental and orthopedic implants.

"ActivOs 10 encompasses the benefits of HA without sacrificing the reliability of a PMMA cement," said Dr. Douglas Beall, chief of radiology services for Clinical Radiology of Oklahoma. "The cement has great handling characteristics, is highly radiopaque and has optimal working time for clinicians to complete the balloon kyphoplasty procedure. I feel comfortable in using it on my patients with spinal fractures caused by cancer or osteoporosis."

In a non-human trial where KYPHON ActivOs 10 Bone Cement with Hydroxyapatite was implanted into eight rabbit femurs, new bone was seen to form on the surface of the cement without an intervening fibrous tissue layer, and no inflammatory foreign body reaction was observed. This suggests that the surface of the cement is compatible with bone.

"With ActivOs 10, we are excited to offer an alternate choice in bone cements for our customers conducting KYPHON Balloon Kyphoplasty," said Alex DiNello, vice president and general manager of the Kyphon Products Division. "With this product, Medtronic continues to leverage our leadership position in balloon kyphoplasty for the treatment of vertebral compression fractures. Since we began marketing this treatment in 2000, an estimated 700,000 fractures have been treated worldwide with KYPHON Balloon Kyphoplasty by approximately 14,000 trained spine specialists."