US-based Simplify Medical has received CE mark approval for its new MRI compatible cervical artificial disc, Simplify Disc.
Simplify Disc is a cervical disc replacement that includes MRI friendly materials, developed to eliminate invasive CT scans, reduce radiation exposure, and offer a metal-free option to patients.
It comprises endplates designed to be compliant with the vertebral bodies under loading common to the cervical spine and includes disc heights as small as 4mm for smaller patient anatomy.
Simplify Medical CEO David Hovda said: "The CE Mark represents a significant achievement for Simplify Medical, enabling us to commercialize our Simplify Disc internationally and expand upon our successful clinical experience that served as the basis for approval.
"MRI imaging is the most accurate option for evaluating soft tissue in the spine, non-invasive for patients, and avoids ionizing radiation and contrast injections associated with CT/Myelograms."
The new disc provides a range of motion similar to intact natural discs, as well as offers streamlined implantation procedure.
The company plans to start US IDE clinical trial in 2015 for the disc, in a bid to leverage its considerable motion preservation experience and clinical data.