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U.S. launch helps patients with vertebral fractures.
July 28, 2010
By: Michael Barbella
Medtronic Inc. has launched a new type of bone cement for patients with vertebral fractures. The cement, which is being marketed and sold in the United States, was developed for use in balloon kyphoplasty surgeries—procedures in which surgeons inflate a balloon to fill the gap created by a fracture before injecting cement into the space. Such surgeries, according to experts, can help restore vertebral height and reduce the chances of spine deformity. Company executives said Kyphon ActivOs 10 Bone Cement with Hydroxyapatite—a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA)—helps broaden the firm’s portfolio of orthopedic cements. Surgeons performing balloon kyphoplasty procedures now can choose between the ActivOs or the Kyphon HV-R Bone cement. “ActivOs 10 encompasses the benefits of HA without sacrificing the reliability of a PMMA cement,” said Douglas Beall, M.D., chief of radiology services for Clinical Radiology of Oklahoma in Edmond, Okla. “The cement has great handling characteristics, is highly radiopaque and has optimal working time for clinicians to complete the balloon kyphoplasty procedure.” HA is chemically and structurally similar to the mineral component of bone, has been widely studied, and has a long history of use in dental and orthopedic implants, experts said. In a non-human trial where Kyphon ActivOs 10 Bone Cement was implanted into eight rabbit femurs, new bone formed on the surface of the cement without an intervening fibrous tissue layer, and no inflammation occurred. The observations lead researchers to conclude 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 balloon kyphoplasty,” said Alex DiNello, vice president and general manager of the Kyphon Products Division. “Since we began marketing this treatment in 2000, an estimated 700,000 fractures have been treated worldwide with balloon kyphoplasty by approximately 14,000 trained spine specialists.”
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