European Regulators Approve Simplify Medical’s Cervical Artificial Disc

Simplify Medical Inc. has received CE Mark approval for its Simplify Disc, a non-metal, MRI-friendly cervical artificial disc.

The product is a cervical disc replacement composed of magnetic resonance imaging-friendly (MRI) materials designed to eliminate invasive computed tomography (CT) scans, reduce radiation exposure, and provide a metal-free option to patients, according to the company. Simplify Disc 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 4 millimeters for smaller patients.

“The CE Mark represents a significant achievement for Simplify Medical, enabling us to commercialize our Simplify Disc internationally and expand upon our clinical experience that served as the basis for approval,” CEO David Hovda said. “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.”   

Simplify Disc enables range of motion similar to intact natural discs, while providing lower disc heights to treat patients with smaller anatomy, and a streamlined implantation procedure, executives noted in a news release announcing the approval. Simplify Medical expects to begin a U.S. IDE clinical study in 2015, leveraging its considerable motion preservation experience and clinical data.   

The Simplify Disc’s Polyetheretherketone-on-ceramic articulation is designed for low levels of wear to optimize long-term durability.

The Journal of Orthopaedic Sports Physical Therapy reports that 22 percent to 70 percent of the U.S. population will have neck pain at some point in their lives, with chronic neck pain lasting more than six months affecting 14 percent of individuals with neck pain. The affliction is second only to low back pain in annual workers’ compensation costs in the United States.

Based in Mountain View, Calif., Simplify Medical develops cervical spinal disc arthroplasty solutions, focusing particularly on those using MRI-friendly materials.