MAITLAND, Fla., Aug. 5 /PRNewswire/ -- Scient’x USA announced today that it will submit an Investigational Device Exemption application to begin clinical trials of its Discocerv(TM) cervical disc replacement in the fourth quarter of this year. The device is unique in that it incorporates ceramic-on- ceramic bearing technology in order to eliminate wear related complications presented by other materials used in total disc replacement.
“The young age of disc patients requires that a replacement may be expected to last for 40 years,” commented Craig Corrance, President of Scient’x USA. “Concerns over osteolysis from polyethylene debris indicate that it is not acceptable as a bearing material in the long term. Indeed, the state of the art for joint replacement in the young active patient is ceramic surfaces. We believe it is even more critical in the disc.”
The Discocerv consists of titanium alloy endplates embedded with ceramic bearing components. Anatomically designed endplates provide intimate contact between the prosthesis and vertebral bodies, leading to excellent primary anchorage of the device. The Discocerv also features a pre-defined lordotic angle to restore the natural curvature of the spine.
“We feel strongly that the debris problem with first generation polyethylene devices will be a critical one in the future,” continued Corrance. “The Scient’x technology will provide the solution, hopefully a permanent one.”
The Discocerv is CE marked and commercialized in several European countries, including Greece, Spain, France and Turkey. Previously, the Scient’x cervical disc technology had been the subject of a European clinical study with implantation of the device dating back to 1999.
Established in 2002, Scient’x USA is focused on the newly evolving markets for dynamic stabilization and motion preservation technologies for spinal surgery. The company is dedicated to meeting the needs of spine surgeons who treat increasingly younger and more active patients.
For information contact: Guillaume Viallaneix Chief Marketing Officer Scient’x USA, Inc. 1015 Maitland Center Commons Suite 106 A Maitland, Florida 32751 USA Phone: (407) 571 2550 Fax: (407) 571 2551
Scient’x USA Inc.
CONTACT: Guillaume Viallaneix, Chief Marketing Officer of Scient’x USA,Inc., +1-407-571 2550, or fax, +1-407-571 2551