Medtronic Inc. (NYSE:MDT) today announced Food and Drug Administration (FDA) clearance of the Kyphon Xpander II Inflatable Bone Tamp (IBT) for the treatment of vertebral compression fractures with minimally invasive Kyphon® Balloon Kyphoplasty.
“Xpander II joins a host of innovative new products in what is the largest launch in our division's history”
Kyphon Xpander II is the latest innovation from the creator of balloon kyphoplasty and maker of the Kyphon Xpander™ IBT. The new IBT is designed to have an improved, pre-determined inflation pattern and exert greater lifting force than that of the Kyphon Xpander™ IBT. It also gives physicians the ability to maintain inflation of one IBT while delivering polymethylmethacrylate (PMMA) bone cement on the contra-lateral side of the vertebrae. Kyphon Xpander II will enter into limited market release in November in the U.S. The product is expected to be available internationally in 2011.
Xpander II is a significant addition to the industry-leading advancements Medtronic has made over the past 10 years in the treatment of vertebral compression fractures - the most common osteoporotic fractures with an estimated 900,000 spinal fractures occurring in the U.S. every year. Vertebral compression fractures have shown to increase the likelihood of additional health problems as well as increase the risk of death. Since the Kyphon Products Division of Medtronic introduced balloon kyphoplasty in 2000, an estimated 800,000 fractures have been treated worldwide with Kyphon Balloon Kyphoplasty by approximately 14,500 trained spine specialists.
"Xpander II joins a host of innovative new products in what is the largest launch in our division's history," said Alex DiNello, vice president and general manager of the Kyphon Products Division. "Xpander II is the flagship product in our division's revitalized product platform, which also includes the Kyphon Express™ Curette, Kyphon ActivOs™ 10 Bone Cement with Hydroxyapatite, and the Kyphon® Cement Delivery System. These new products join the rest of our product family in providing our customers with performance they can count on in treating vertebral compression fractures."