DePuy Synthes gets FDA clearance for use of fenestrated screw systems in spinal tumours

26 January 2017 (Last Updated January 26th, 2017 18:30)

DePuy Synthes has secured the US Food and Drug Administration (FDA) 510(k) clearance for the use of Viper and Expedium Fenestrated screw systems in patients with advanced stage spinal tumours.

DePuy Synthes has secured the US Food and Drug Administration (FDA) 510(k) clearance for the use of Viper and Expedium Fenestrated screw systems in patients with advanced stage spinal tumours.

To be used in combination with Confidence High Viscosity Spinal Cement, the screws are designed to restore the integrity of the spinal column through open or percutaneous spinal fusion surgery.

Designed with a hollow shaft or cannulation, the screws can be used to surgically stabilise the spinal column, decrease pain and help keep the patient mobile.

"There is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely."

The holes, called fenestrations present above the screw tip allow controlled delivery of Confidence High Viscosity Spinal Cement into the vertebra to enable instant screw fixation.

DePuy Synthes Spine Research & Development vice-president William Horton said: "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.

"We designed these fenestrated screw systems to help address those needs, and to facilitate minimally invasive solutions for patients suffering from this disease."

The Viper Fenestrated screws are compatible with the Viper and Expedium 5.5 spine systems, while the Expedium Fenestrated screws are compatible with the Expedium Verse spinal system.

Both fenestrated screw systems are expected to be available in the US by mid this year.

A division of Johnson & Johnson, DePuy Synthes develops solutions for joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine.