Cambridge, England -- Medical device developer Ranier Technology has gained CE Mark approval for its Cadisc-L, which is an elasto-mimetic spinal-disc replacement device for the lumbar spine. The company said the approval followed a review of its multi-centre European clinical study and its extensive portfolio of biocompatibility and biomechanical testing.
"The initial outcomes in the clinical study are very pleasing. By using the Cadisc-L spinal disc replacement, we found patients had significant reductions in average leg and back pain, and overall disability, and coupled with an increase in quality of life there are very strong indications of early phase performance," said Dr Geoffrey Andrews, Ranier's ceo, in a 13 Sept company statement.
The CE Mark "is a very significant milestone," for Ranier Technology, allowing the company to implement plans to commercialise the Cadisc-L technology in European healthcare markets, said Andrews, adding that this can transform "quality of life to thousands currently suffering from debilitating back pain."
Cadisc- L is intended to treat degenerative disc disease of the lumbar spine, a debilitating condition causing severe back & leg pain which seriously impairs the lives of millions. Currently over half a million patients every year undergo conventional surgery which removes the diseased disc and fuses the two adjacent vertebrae together, restricting further motion, said Ranier's statement.
In what it calls "a significant development," scientists at Ranier have utilised the elastomeric and load bearing properties of the company's Precision Polyurethane Manufacturing technology to develop a polymeric replacement disc which more closely mimics the biomechanical performance of the natural disc.
The new design aims to restore the natural, elastomeric motion to the spine, to share the high loads encountered in the lumbar spine with adjacent tissues and to reduce patients' pain, allowing them to regain their former active lifestyles and enjoy a normal quality of life, Ranier said.