Medtronic’s AdaptiveStim with RestoreSensor neurostimulation system has been found to be more effective at treating chronic back or leg pain than conventional stimulation.
The study involved 79 patients at ten centres in the US, and 76 patients received implants.
According to the company, 86.5% of study participants with chronic pain, who were included in an intent-to-treat analysis (n=74), reported pain relief.
During the multicentre, prospective, open-label and randomised, crossover study, 80.3% subjects also reported functional improvements, including improved comfort during position changes.
The patients were randomised to receive either stimulation from the RestoreSensor solution for six weeks with the AdaptiveStim technology switched on followed by six weeks with AdaptiveStim switched off, or six weeks with AdaptiveStim turned off followed by six weeks with AdaptiveStim turned on.
According to physicians, 88.7% of participants reported clinical benefits from the system, which uses motio-sensor technology to provide pain relief.
The system also helps clinicians in understanding how a patient’s stimulation requirements are changing over time.
Trial investigator David Schultz said that the study "clearly demonstrates the effectiveness of position-adaptive stimulation technology in providing pain relief and convenience to patients suffering from chronic pain, so they can lead more normal lives".
The US Food and Drug Administration approved the AdaptiveStim with RestoreSensor for the management of chronic pain.