DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screw Systems

RAYNHAM, Mass., Jan. 26, 2017 /PRNewswire/ -- DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER^® and EXPEDIUM^® Fenestrated Screw Systems. When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery. 

Metastatic spine disease accounts for 10 percent to 30 percent of new cancer diagnoses annually.¹ Surgical fixation with pedicle screws may be used as palliative care to stabilize the spine, help reduce pain and help keep the patient mobile.¹ 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 CONFIDENCE™ 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," said William C. Horton, M.D., Vice President of Research & Development, DePuy Synthes Spine. "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 and the EXPEDIUM Fenestrated Screws are compatible with the EXPEDIUM VERSE Spinal System. Both fenestrated screw systems are anticipated to be available in the United States in mid-2017.

Indications for Use

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER^® and EXPEDIUM^® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER^® and EXPEDIUM^® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates. Medos International, SARL is the legal manufacturer of the VIPER and EXPEDIUM Fenestrated Screw Systems.

DSUS/SPN/0117/1510 01/17

¹ Dunning, E.C, et al. Complications in the management of metastatic spinal disease. World J Orthop. 2012 Aug 18; 3(8): 114–121.

SOURCE DePuy Synthes