Medtronic's new inflatable bone tamp cleared by FDA
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Medtronic's Kyphon Xpander II inflatable bone tamp (IBT). The product is designed for use during minimally-invasive Kyphon balloon kyphoplasty, which is used to treat vertebral compression fractures. The IBT is inserted into the vertebral body and inflated to create a void into which bone cement is delivered. The product is an updated version of the firm's original Kyphon Xpander IBT, which received FDA clearance in 1998. The new IBT is designed to have an improved, pre-determined inflation pattern and exert greater lifting force than the older product. Minneapolis, Minnesota-based Medtronic plans to CE mark the Kyphon Xpander II for sale in Europe in early 2011, the firm told Clinica.