The US Food and Drug Administration (FDA) has cleared Medtronic Kyphon Xpander II Inflatable Bone Tamp (IBT) for the treatment of vertebral compression fractures with minimally invasive Kyphon Balloon Kyphoplasty.
Kyphon Xpander II IBT is the latest product 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 pattern1 and exert greater lifting force than that of the Kyphon Xpander IBT, Medtronic said.
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 vertebrae2.
Kyphon Xpander II will enter into limited market release in November in the US.
The product is expected to be available internationally in 2011.
Kyphon Products Division vice president and general manager Alex DiNello said that Xpander II is the product in the division’s revitalised product platform, which also includes the Kyphon Express Curette, Kyphon ActivOs 10 Bone Cement with Hydroxyapatite, and the Kyphon Cement Delivery System.