Simplify Cervical Disc: First U.S. Patient, Two Adjacent Levels
Elizabeth Hofheinz, M.P.H., M.Ed. • Mon, May 1st, 2017
Simplify Medical Inc.’s low-metal, low-wear Simplify cervical artificial disc has now been used in its first U.S. patient and it was placed in two adjacent levels of the spine as a treatment for cervical degenerative disc disease. The case took place at Texas Back Institute.
According to the company, “The Simplify Disc is designed to be clearly viewed on magnetic resonance imaging (MRI) without the artifact that can result from metal used in typical spine implants, potentially protecting patients from radiation associated with computed tomography (CT) scans.”
Following the first case at Texas Back Institute, Simplify Disc IDE study investigator John Peloza, M.D. said, “Disc implantation went smoothly and the patient is doing quite well.” Dr. Peloza, medical director of the Center for Spine Care, continued, “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 minimize overdistraction, which may improve outcomes in multi-level procedures.”
Richard Guyer, M.D., chairman of the Texas Back Institute Foundation and national co-primary investigator for the study said, “We are excited to start the Simplify Disc Two-Level IDE [investigational device exemption] study. The device is made of materials designed to optimize its viewing and viewing of the adjacent spinal canal on MRI without artifact. This may eliminate or minimize the use of post-operative CT scans and reduce the risk of the associated radiation to the patient.”
“The prospective, randomized controlled Simplify Disc pivotal trial will encompass up to 215 patients at up to 15 centers and will compare cervical implantation of two contiguous discs from C3 to C7 with two-level cervical fusion surgery,” says the company news release.
“Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a simple, three-step procedure.”
Simplify President and CEO David Hovda told OTW, “Surgeons have often told me an anatomic disc replacement with lower heights to better match patient’s cervical anatomy would be important for optimizing long term clinical outcomes. For two-level procedures, these design features should be even more important than in a single-level application. We look forward to continuing our two-level IDE study and studying the clinical benefit of Simplify Disc for this important indication.”
“The Simplify Disc is unique in several ways. By being fully viewable on MRI post-surgery, it minimizes patients’ exposure to significant radiation from CT scans. Having no metal in its articulating components, the Simplify Disc is optimized for long-term durability and avoids metal wear problems associated with some devices. Implantation is a very straightforward, three-step procedure. The disc also offers a variety of heights down to 4mm, which makes it ideal for female patients and others with smaller cervical disc spaces, such as certain regions.”