FDA approves DePuy Synthes’ cement-augmented pedicle screw systems

This article was originally published here

MDBR Staff Writer Published 27 January 2017

Johnson & Johnson’s unit DePuy Synthes has received approval from the US Food and Drug Administration (FDA) for its Viper and Expedium fenestrated screw systems.

The cement-augmented pedicle screw systems have been developed for use in open or percutaneous spinal fusion surgery.

The screws will restore the integrity of the spinal column in patients with advanced stage spinal tumors, when used in conjunction with Confidence high viscosity spinal cement.

Both the screws were designed with a hollow shaft or cannulation. This design, along with holes called fenestrations above the screw tip, will facilitate controlled delivery of Confidence high viscosity spinal cement into the vertebra to offer immediate screw fixation.

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

The company intends to commercially introduce both fenestrated screw systems in the middle of this year.

DePuy Synthes Spine research and development vice president Dr 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.”

DePuy Synthes produces joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine solutions.

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