Neo Pedicle Screw System for spinal fusion surgery

Level of innovation

Two commentators agreed that the Neo Pedicle Screw System (Neo PSS) is a variation on existing technologies, with 1 stating that it provides a single‑use disposable option. Another commentator noted that the Neo PSS has some value in reducing the tray space needed during surgery. The commentators felt that little training would be needed to use the system.

Potential patient impact

Two commentators did not expect the Neo PSS to improve patient health outcomes, and none felt that there would be any change to patient experience. Two commentators stated that it could potentially reduce the risk of infection, but evidence from studies would be needed to prove this. One noted that Neo PSS could prevent the incidence of surgery being cancelled because a hole is found in the cover of conventional trays of instruments.

One commentator noted that single‑use devices also have the potential advantage of reduced exposure to Creutzfeldt–Jakob disease when used in patients born after 1996 and when there is a breach of the dura mater (outermost membrane that surrounds the spinal cord and brain).

Potential system impact

The commentators did not identify any significant effect on NHS services, facilities and infrastructure. One commentator believed that the Neo PSS could be associated with reduced sterilisation costs, if these are significant, and improved theatre efficiency. Two commentators noted that it needs less storage space than other systems. One stated that using Neo PSS would lead to a lot of disposable packaging needing to be removed after surgery, and that there is a cost associated with this.

The commentators did not see any clear cost savings associated with using the Neo PSS. One felt that in order to identify any cost saving, the cost of sterilising reusable instruments would need to be assessed.

General comments

Two commentators noted that the use of Neo PSS would be limited to straightforward surgeries, because other instruments would be needed for patients with variations to their anatomy, where correction of deformity or bone reduction is needed, or to correct segment deformity.

Two commentators stated that they did not have concerns over how repeated sterilisation procedures may affect the integrity of the instruments; neither had seen evidence to show that sterilisation caused damage or metal fatigue. Another commentator noted that instruments have a stated shelf-life, after which they are disposed of.