Simplify Medical has announced that the first patient has been treated in the company’s pivotal clinical trial studying use of the Simplify disc in two adjacent levels of the spine as a treatment for cervical degenerative disc disease.
Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify disc is designed to be viewed by magnetic resonance imaging (MRI). With no metal in its articulating components, the disc is also designed for low levels of wear to optimise long-term durability. Implantation of the Simplify Disc is accomplished in a simple, three-step procedure. The Simplify disc is designed with low height implant options to accommodate patients with smaller cervical disc spaces. The device is considered MRI-conditional.
Following the first case at Texas Back Institute, Plano, USA, Simplify Disc investigative device exemption (IDE) study investigator and medical director of the Center for Spine Care, Dallas, USA, John Peloza, says, “Disc implantation went smoothly and the patient is doing quite well…I look forward to studying the use of the Simplify disc at two levels, in collaboration with the Texas Back Institute team. I believe the Simplify disc’s anatomic design with lower heights can help minimise overdistraction, which may improve outcomes in multilevel procedures.”
Richard Guyer, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, says, “We are excited to start the Simplify disc two-level IDE study. The device is made of materials designed to optimise its viewing and viewing of the adjacent spinal canal on MRI without artefact. This may eliminate or minimise the use of post-operative computed tomography (CT) scans and reduce the risk of the associated radiation to the patient.”
The prospective, randomised controlled Simplify Disc pivotal trial will encompass up to 215 patients at up to 15 centres and will compare cervical implantation of two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The composite primary endpoint includes functional improvement, pain relief and safety. The national co-principal investigators are Domagoj Coric, chief of the department of neurosurgery, Carolinas Medical Center, Charlotte, USA, and Guyer.
The company is also enrolling patients in a second pivotal trial comparing one-level cervical implantation of the disc between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group.
The Simplify disc has received CE mark and has been used to treat more than 600 patients outside the USA over the last three years. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.