Ranier Technology has received CE mark approval for its replacement disc for the cervical spine, Cadisc-C. The implant is designed to mimic the biomechanics of the natural cervical disc and also features uniquely a non-metallic, compliant bone integrating surface.
The CE mark approval was received following a review of the company’s multicentre European clinical study and its extensive portfolio of biocompatibility and biomechanical testing.
Dick Zeilstra, Bergman Clinics, Naarden, Holland, who is leading the clinical study for Cadisc-C, said, “The Cadisc-C disc design is closest to physiological function compared to those currently available for cervical arthroplasty and it has the potential for improved patient outcomes. It is also as easy to insert as a conventional cage and hardly requires any extra operating time.”
“The achievement of the CE mark for our Cadisc-C cervical disc is a significant milestone that will allow us to implement plans for full commercialisation of this technology in European healthcare markets in early 2012, with the potential to bring relief and a transformed quality of life to thousands of people currently suffering from debilitating neck and arm pain. There is significant un-met clinical need in this area and we are confident that Cadisc-C provides a significant technical advance over other currently available cervical discs and that it will be an attractive option for surgeons and patients alike,” commented Geoffrey Andrews, founder and CEO of Ranier Technology.
The CE mark for Cadisc-C follows CE mark approval for Ranier’s Cadisc-L lumbar spinal disc last year.
“The Cadisc-C like the Cadisc-L last year brings a complete new technology to the armamentarium of a spine surgeon. Namely, a true artificial copy and imitation of a regular intervertebral disc in the form of a polyurethane prosthesis, which consists of a nucleus as well as an annulus component and highly sophisticated cranial and caudal surfaces which interface with the vertebral endplates in an unique way and without any metal. This is a paradigm shift in the concept of disc replacement surgery and opens a new chapter for patient care in degenerative disc disease,” said, Max Aebi, chief of Staff at the Orthopaedic Hospital Salem in Bern, Switzerland, and chairman of Ranier’s Scientific Advisory Board.
Cadisc-C is a next generation intervertebral disc designed to restore height and functionality to degenerate discs in the cervical spine. The Cadisc-C cervical disc is an anatomically shaped, single piece, polycarbonate polyurethane implant with no articulating surfaces and has material properties, including a graduated modulus, which aims to mimic the biomechanical properties of the natural cervical disc. The innovative design aims to reduce the amount of surgical preparation necessary at the implantation site and promotes maximum stability and resistance to migration.