Simplify Medical, Inc. says its non-metal, MRI friendly Simplify DiscTM cervical artificial disc has gained CE mark approval.
Simplify Disc is a cervical disc replacement composed of the a combination of PEEK and ceramic MRI friendly materials, which means this diagnostic modality can be used in preference to more invasive CT scans. This means reduced radiation exposure, while providing a metal-free option to patients. Simplify Medical says its implant has endplates designed to be more 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 Disc claims to enable a range of motion similar to intact natural discs, while providing lower disc heights to treat patients with smaller anatomy, and a streamlined implantation procedure.
Simplify Medical expects to begin a U.S. IDE clinical study in 2015, leveraging its considerable motion preservation experience and clinical data.
“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,” said Simplify Medical CEO, David Hovda. “Because we have MRI friendly, durable materials using advanced medical polymers and ceramic, we can provide a metal-free solution to surgeons and patients. 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.”
Source: PR Newswire