The FDA has cleared Medtronic plc’s latest anterior cervical plate system for anterior cervical discectomy with fusion (ACDF) procedures.
The ZEVO system is now commercially available for the treatment of “cervical disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions, ” according to a company announcement. The system features lower-profile plates with minimal thickness (1.9mm and 2.1mm) while increasing the stability of the construct for the 4-5 level options.
In a May 4, 2015 announcement, the company said the system features shorter plating options coupled with hyper-screw angulations, “allowing the physician to select the smallest possible plate for the patient’s individual surgical needs while securing the plate as far as possible from the adjacent disc.” The company cited literature which shows this technique may lower the incidence of Adjacent Level Ossification Development (ALOD) or bone growth next to the treated level.
Doug King, president of Medtronic’s spine business, said versatility is important in ACDF procedures and that this system was designed to give surgeons more options.
Thinner Plates, Hyper Screw Angulation
Richard Hynes, M.D., a spine surgeon at The B.A.C.K. Center in Melbourne, Florida, said, “Improved, thinner plates are important in ACDF procedures. ZEVO embodies these characteristics, with the added benefits of hyper screw angulations, which can be directed away from the spinal cord.”
The system’s plate and bone screw components, according to the company, are intended for anterior interbody screw fixation from C2-T1. “The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.”
Risks of the system include “early or late loosening of any or all components and the development of new radiculopathy, myelopathy or pain, and/or tissue or nerve damage caused by improper positioning and placement of implants or instruments.”
