2.1 The Senza spinal cord stimulation (SCS) system (Nevro) is a neuromodulation device that delivers electrical impulses to the spinal cord. The treatment Senza provides (known as HF10 therapy) is a combination of high-frequency (10 kHz) low-amplitude electrical pulses designed to relieve pain and not be felt by the patient, and a proprietary programming algorithm. The impulses are delivered by small electrodes, which are placed in the spinal epidural space and are connected to a small, battery-powered pulse generator that is implanted under the skin. The strength, duration and frequency of the electrical pulses can be controlled remotely. HF10 therapy using Senza SCS is referred to as Senza in the main body of this guidance.
2.2 Senza was CE marked as a class III device in May 2010 and is intended to be used only for patients who have had effective pain relief in a trial of stimulation. Patients who have a Senza device in place should not have shortwave, microwave or therapeutic ultrasound diathermy because of the risk of severe injury or death. They should only be exposed to MRI under conditions outlined in the instructions for use and the full-body MRI conditional label issued in November 2017.
2.3 The company also offers a newer system called Senza II, which delivers the same HF10 therapy. Senza II is intended for use in patients with a low BMI who need a smaller device. It has not been considered as part of this evaluation.
2.4 The acquisition cost of Senza, as stated in the company's submission, is £16,648 (excluding VAT). This includes electrodes, leads, an implantable pulse generator (with rechargeable battery), a remote control and a battery charger.
2.5 The claimed benefits in the case for adoption presented by the company are that, compared with low‑frequency SCS, Senza is associated with:
clinically superior pain relief, as well as better clinical and functional outcomes, for most people with back or leg pain
no paraesthesia, so treatment can be continued during sleep and while driving or operating machinery
sustained and long-term improvement in pain relief and function, which may reduce the need for pain medication and follow-up attendance at pain clinics
no need for paraesthesia mapping during implantation, which allows for shorter and more predictable procedure times.
2.6 The NICE technology appraisal guidance on spinal cord stimulation for chronic pain of neuropathic or ischaemic origin recommends SCS as a treatment option for adults with chronic pain of neuropathic origin that continues for at least 6 months despite conventional medical management (including pharmacological treatment, physiotherapy and psychological support) who have had a successful trial of stimulation as part of a wider assessment by a multidisciplinary team. SCS is not recommended for adults with chronic pain of ischaemic origin, except in the context of research. The devices considered in the guidance deliver low‑frequency SCS. The guidance was last reviewed in 2013, before all the evidence on Senza considered in this evaluation was available. The review concluded that more recent evidence would be unlikely to change the recommendations, and the guidance was placed on the static list.
2.7 NICE has also produced related guidelines on neuropathic pain in adults in non-specialist settings and low back pain and sciatica in over 16s.