The US Food and Drug Administration (FDA) has cleared Medtronic's AdaptiveStim with RestoreSensor neurostimulation system for the management of chronic back and/or leg pain.
The AdaptiveStim with neurostimulator utilizes motion sensor technology which provides effective pain relief and convenience by automatically adjusting stimulation levels to the needs of people with chronic pain.
The FDA approval is based on a multicenter, open-label, prospective, randomized US RestoreSensor study, which enrolled 79 patients and showed that the AdaptiveStim with RestoreSensor neurostimulator provides effective pain relief and convenience.
MAPS Pain Clinics and MAPS Applied Research Center (MARC) founder and medical director and RestoreSensor clinical trial investigator David Schultz said this research provides important clinical evidence that demonstrates this position-sensing technology improves pain management and makes it easier for patients suffering from chronic pain to better manage their symptoms when compared to systems that require manual changes in stimulation.
Medtronic said AdaptiveStim with RestoreSensor is approved by the FDA for use in MRI head scans if recommended by a physician.