MINNEAPOLIS – June 21, 2010 – 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 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 studiedi, 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.”
Important Safety Information
The complication rate with KYPHON Balloon Kyphoplasty has been demonstrated to be low.ii There are risks associated with the procedure (e.g., cement leakage), including serious complications, and though rare, some of which may be fatal. This procedure is not for everyone. A prescription is required. Please consult a qualified physician for a complete list of indications, contraindications, benefits, and risks. Only a patient and his or her physician can determine whether this procedure is appropriate for individual cases.
More information about KYPHON ActivOs 10 Bone Cement with Hydroxyapatite can be found at www.kyphon.com.
About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business is based in Memphis, Tenn. It is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spinal and Biologics business works with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic, dental and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle-friendly surgical therapies. More information about the company and its treatment therapies can be found atwww.medtronic.com and its patient-education Web sites, www.back.com,www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
KYPHON® Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.
i LeGeros RZ. Properties of Osteoconductive Biomaterials: Calcium Phosphates. Clinical Orthopaedics and Related Research. 2002; 395:81-98.
ii Based on analysis of 93 published studies with 5,690 KYPHON Balloon Kyphoplasty patients through April 4, 2010. Cement related symptomatic adverse events were 0.21 percent. Data on file as of June 21, 2010.
*This response of providing a direct bony apposition on the surface of the cement without any intervening fibrous tissue layer has not been assessed in any clinical investigations and the results from animal testing may not be predictive of human clinical experience.