Simplify Medical said today that it launched a pivotal study of its eponymous cervical disc, which is designed to be safe during magnetic resonance imaging scans.
Sunnyvale, Calif.-based Simplify said the implant is “optimized” for MRI scans in that it’s designed to eliminate the imaging artifact created by the metals used in some artificial disc replacements, using a PEEK-on-ceramic construction. The aim is to eliminate the need for computed tomography scans after implantation and the attendant patient exposure to ionizing radiation. The Simplify disc won CE Mark approval in the European Union in February 2015.
The 215-patient trial is designed to compare the Simplify disc, implanted at a pair of adjacent discs from C3 to C7, with 2-level fusion surgery. The primary endpoint includes functional improvement, pain relief and safety, Simplify said. The study, of patients treated at 2 adjacent levels of the cervical spine, saw its 1st patient treated at the Texas Back Institute, the company said.
“We have designed the Simplify disc to be responsive to surgeons’ needs, providing them with the potential to improve patient outcomes,” CEO David Hovda said in prepared remarks. “We are enthusiastic about moving forward with the pivotal trial.”
“Disc implantation went smoothly and the patient is doing quite well,” added Dr. John Peloza, who performed the 1st implantation. “I look forward to studying the use of the Simplify disc at 2 levels, in collaboration with the Texas Back Institute team. I believe the Simplify disc’s anatomic design with lower heights can help minimize over-distraction, which may improve outcomes in multi-level procedures.”
“We are excited to start the Simplify disc 2-level IDE 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,” co-principal investigator Dr. Richard Guyer said.
Simplify Medical, which was acquired by Australian private equity shop M.H. Carnegie for an undisclosed amount in March 2015, is running another study comparing its device in single-level cervical implantations between C3 and C7 with cervical fusion.