Ranier Technology Gets CE Mark Approval for Spinal Device

CE Mark approval has been granted to Ranier Technology Limited for its Cadisc-L, a spinal disc replacement device for the lower back.

The Cadisc-L, according to the Cambridge, England-based company, is a plolyurethane-polycarbonate graduated modulus replacement spinal implant that mimics the bio-mechanical properties of the lower back to restore intervertebral height and curvature. Like the body’s natural vertebral discs, the Cadisc-L has a compliance that reduces the degeneration of adjacent discs observed when diseased discs are surgically replaced with rigid, non-compliant structures, the company reported. In addition, Cadisc-L has no articulating surfaces, thus minimizing the potential for wear debris.

“The achievement of the CE Mark for our Cadisc-L lumbar disc product is a very significant milestone,” said Dr. Geoffrey Andrews, Ranier CEO. “It will allow us to implement our plans for full commercialization of the technology in European healthcare markets … Having met both prospective patients and recipients of Cadisc-L, I know there is a great unmet clinical need that Cadisc-L can be highly successful in addressing.”

According to clinical study results, patients who had discs in their lower back replaced with the Cadisc-L had less leg and back pain and an improved quality of life, said Ian Quirk, director of Clinical and Regulatory Affairs at Ranier.

Degenerative disc disease is a spinal condition caused by the breakdown of the intervertebral discs. As a result of the natural aging process, the spine begins to show signs of wear and tear as its discs dry out and shrink. These age-related changes can lead to arthritis, disc herniation, or spinal stenosis, which can put pressure on the spinal cord and nerves and may cause back pain. About 1 million people worldwide are treated surgically each year for lumbar disc defects, with more than 500,000 receiving a spinal fusion procedure in which the diseased disc is removed and replaced with a rigid fixture, according to the company.

Ranier has developed a technology called precision polyurethane manufacturing (PPM) that enables the design and production of load sharing, polyurethane implants with regions of graduated rigidity. The PPM technology confers both programmable mechanical properties and high durability.