Subjects recruited from six comprehensive pain centers in Australia who met the inclusion/exclusion criteria and signed informed consent were enrolled in the study. This prospective, open-label feasibility study was conducted to obtain clinical data on the safety and efficacy of a neurostimulation system for SCS (Nalu Medical, Inc, Carlsbad, CA). In addition, we hypothesize that the pulsed stimulation pattern (PSP) waveform provides pain relief that is comparable with other commercially available waveforms. The design hypothesis for this novel, battery-free, miniaturized IPG is to provide a comfortable system to patients that decreases pain at the implant site owing to its small size (< 1.5 cm 3) compared with historical SCS systems with larger implants. In addition, the unique microchip design of the system allows software upgrades over time for additional capabilities, parameters, and therapy options. This IPG (< 1.5 cm 3) delivers pulses to one or two percutaneous leads (up to eight contacts each) placed in the epidural space for SCS or in proximity to a nerve for peripheral nerve stimulation and can support a broad menu of therapy options, including novel waveforms.
The device is not cleared to treat pain in the craniofacial region. The FDA has cleared the system for two indications: 1) SCS as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain and 2) peripheral nerve stimulation for pain management in adults who have severe, intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. Recently, a battery-free, miniaturized IPG, < 1.5 cm 3 volume, has been developed that is powered by a small, externally worn battery pack (Therapy Disc ).