Advice

The technology

The technology

The Evoke system (Saluda Medical) is a rechargeable, implantable, closed-loop stimulator for chronic pain management. The system is made up of an implantable closed-loop stimulator (an external stimulator is used during an initial trial period), 1 or 2 12-contact leads connecting the stimulator to the spinal cord, a remote control for manually changing stimulation and a charging kit. The stimulator (external or implantable) is programmed to deliver therapeutic spinal cord stimulation using feedback control with the Evoke Clinical Interface and Evoke Clinical System Transceiver. Evoke can be programmed and used as an open-loop (which gives a fixed output of stimulation) spinal cord stimulation system, similar to conventional spinal cord stimulation systems.

Innovations

Evoke uses feedback control by recording activation of neural tissue and automatically adjusting spinal cord stimulation to ensure it remains in the therapeutic range. The company claims using Evoke could improve pain management and reduce follow-up appointments.

Current care pathway

Treatment for chronic pain is to make pain tolerable and improve people's functionality and quality of life. In cases when the cause of the pain cannot be treated, pain pathways are adjusted to manage the pain severity. People presenting with chronic pain will be assessed by a multidisciplinary team experienced in managing chronic pain. Treatment is based on the presentation and severity of the pain and includes pharmacological and non-pharmacological interventions. Pharmacological interventions include non-steroidal anti-inflammatory drugs, tricyclic antidepressants, anticonvulsants, analgesics and opioids. Non-pharmacological interventions include physiotherapy, psychological therapy and spinal cord stimulation. Spinal cord stimulation is recommended for people who have neuropathic pain and have had a successful spinal cord stimulation trial.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

Evoke is intended as a replacement or alternative to the current open-loop spinal cord stimulation systems used in standard care to treat chronic, intractable pain. Deciding to implant the permanent Evoke closed-loop stimulator would depend on the successful completion of a trial period using the Evoke external closed-loop stimulator.

Treatment would be managed by a multidisciplinary team with experience in neuromodulation. The Evoke system would be implanted by specialist pain consultants or surgeons in an operating theatre. Programming is carried out by specialist pain nurses or specialist pain consultants. Follow-up procedures can take place on wards or in outpatient departments.

Costs

Technology costs

Evoke costs include the cost of the permanent device with either 1 or 2 leads.

  • Evoke with 1 lead costs £17,595 (including electrodes, leads, implantable pulse generator, remote control, and battery charger).

  • Evoke with 2 leads costs £19,395 (including electrodes, leads, implantable pulse generator, remote control, and battery charger).

The cost does not include the trial phase. The trial phase cost ranges from £1,920 to £4,975.

Costs of standard care

NICE's technology appraisal guidance on spinal cord stimulation for chronic pain of neuropathic or ischaemic origin describes spinal cord stimulation devices (including stimulator, controller and charger, but excluding leads) as ranging from £6,858 to £13,289. The cost of leads ranges from £928 to £1,804 for surgical implantation and £1,065 to £1,158 for percutaneous implantation. However, these costs were last reviewed in 2013. NICE's medical technologies guidance on Senza spinal cord stimulation system for delivering HF10 therapy to treat chronic neuropathic pain reports more recent costs:

  • Senza costs £16,648 (including electrodes, leads, implantable pulse generator, remote control, and battery charger).

  • Non-rechargeable spinal cord stimulation system costs £11,281 (from £8,888 to £14,516), with a lifespan of 4 years.

  • Rechargeable spinal cord stimulation system costs £17,422 (from £13,726 to £22,418).

An updated version of the Senza spinal cord stimulation system is now available, called Senza Omnia (2500). Costs may be higher than those listed above. Experts noted that the device costs listed here may have changed since the time of the NICE publication.

Resource consequences

The device has been launched in the UK and is currently being used in 5 trusts.

Evoke would be used as a replacement option for current open-loop spinal cord stimulation devices in the NHS and the care pathway would remain unchanged. The costs for Evoke are in the range of conventional open-loop spinal cord stimulation systems currently available in the NHS.