DePuy Synthes receives US FDA clearance for cement-augmented pedicle screw systems

DePuy Synthes’ Viper and Expedium systems

DePuy Synthes has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Viper and Expedium fenestrated screw systems. When used in conjunction with high-viscosity spinal cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumours.

The Viper and Expedium fenestrated screw systems can be used in open or percutaneous spinal fusion surgery.

The Viper and Expedium fenestrated screws are designed with a hollow shaft, or cannulation. This design along with holes called fenestrations above the screw tip enable controlled delivery of high-viscosity spinal cement into the vertebra to provide immediate screw fixation.

“Metastatic disease in the spine can be severely painful and limiting for patients who are really trying to maintain quality of life, and there is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely,” says William Horton, vice president of Research & Development, DePuy Synthes Spine.

Both fenestrated screw systems are anticipated to be available in the USA in mid-2017.