RAYNHAM, Mass. – June 29, 2017 – Today DePuy Synthes* announces the U.S. launch of 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 fenestrated screw systems providestabilization and palliative treatment for patients who may be suffering from spinal cord compression as a result of advanced stage tumors.
Surgical treatment for patients with advanced stage spinal disease can be challenging with traditional pedicle screw systems, but using fenestrated screws with spinal cement can provide immediate screw fixation while stabilizing the spine. The VIPER and EXPEDIUM Fenestrated Screws are designed with a hollow shaft, or cannulation. This design along with fenestrations above the screw tip enable controlled delivery of CONFIDENCE High Viscosity Spinal Cement into the vertebra to provide immediate screw fixation.
“The ability to inject cement via fenestrated screws is a true game-changer in the field of spinal oncology,” said Daniel Sciubba**, M.D., Director, Spine Tumor and Spine Deformity Surgery, Johns Hopkins Hospital. “The systems are reliable and easy-to-use and can seamlessly be incorporated into open and minimally invasive approaches. The cement working characteristics, delivery system and ability to use standard hardware and tools make the systems extremely efficient.”
The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery. The use of VIPER Fenestrated Screws combined with spinal cement can be used in minimally invasive surgery (MIS), a type of surgery that is associated with a reduction in operating room time, blood loss and lower infection rates. The VIPER Fenestrated Screws are compatible with the instrumentation of the VIPER and EXPEDIUM 5.5 Spine Systems, and the EXPEDIUM Fenestrated Screws are compatible with the instrumentation of the EXPEDIUM VERSE® Spinal System. Both fenestrated screw systems are now available nationwide.
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 Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies 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, visitwww.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.
**Consultant to DePuy Synthes Spine
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.
©DePuy Synthes 2017. All rights reserved.