Simplify Medical has announced that it has received a CE mark for its Simplify Disc. CE mark allows for marketing and commercialisation in the European Union and additional countries that accept the CE mark. The ISO13485 certification of the device was obtained in 2008.
Simplify Disc is a cervical disc replacement composed of MRI-friendly materials designed to eliminate invasive CT scans, reduce radiation exposure, and provide a metal-free option to patients. The disk 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.
“The CE mark represents a significant achievement for Simplify Medical, enabling us to commercialise our Simplify Disc internationally and expand upon our successful clinical experience that served as the basis for approval,” said Simplify Medical chief executive officer 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.”
The company says that the Simplify Disc enables 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 US IDE clinical study for the device in 2015.