English-based Ranier Technology recently received CE Mark approval for the company's Cadisc-L; an elasto-mimetic spinal disc replacement device for the lumbar spine. The device is intended to treat DDD (degenerative disc disease) of the lumbar spine.
Dr. Geoffrey Andrews, CEO of Ranier said the approval will allow the company to implement plans for full commercialization of the device in Europe.
Initial Outcomes
“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,” added Ian Quirck, the company's director of clinical and regulatory affairs.
The company believes the utilization of the elastomeric and load bearing properties of the company's PPM (precision polyurethane manufacturing) technology to develop a polymeric disc is a significant development. This past July, the company announced a European patent grant (#01953244.9 based on PCT/GB2001/03441) for the PPM technology.
PPM Technology
According to a company statement, the PPM technology "employs process intensification and control to manufacture consistent and reproducible polyurethanes, characteristics that are fundamental to the success of any medical polymer. The dynamic control of the reaction conditions and stoichiometry provided by the PPM process, also facilitate the provision of a reactive material feed that enables the design and production components with regions of graduated hardness, conferring both programmable mechanical properties and high durability under load."
In addition to the Cadisc-L, Ranier also manufactures a compliant lumbar total disc implant, Cadisc-C, a total replacement disc for the cervical spine. The company's current focus is on total disc implants, but believes its PPM technology platform is suited to a wide range of orthopedic applications. Ranier also produces a range of surgical instruments in support of the company's discs.
