Medtronic has received FDA approval for its AdaptiveStim with RestoreSensor neurostimulation system. The system uses motion sensors to detect changes in a patient’s posture and activity and then automatically adjusts the level of electrical stimulation needed for relief of chronic pain symptoms.
With other neurostimulation devices, patients have to use a handheld patient programmer to make manual adjustments to their stimulation levels as their physical activity changes.
From the press release:
AdaptiveStim with RestoreSensor reduces the need for manual programming changes by automatically adapting stimulation levels to the needs of people with chronic back and/or leg pain by recognizing and remembering the correlation between a change in body position and the level of stimulation needed. It also records and stores the frequency of posture changes, providing objective feedback to clinicians to help them understand how a patient’s individual stimulation requirements are changing over time. Additionally, AdaptiveStim with RestoreSensor is approved by the FDA for use in MRI head scans if recommended by a physician. Medtronic is the only company to offer neurostimulators with this approved labeling for use in MRI head scans.
Data from the U.S. RestoreSensor clinical trial demonstrate that the AdaptiveStim with RestoreSensor neurostimulator provides effective pain relief and convenience. At the end of the study, 86.5 percent of study participants with chronic pain, who were included in an intent-to-treat analysis (n=74), experienced somewhat better or much better pain relief with no loss of convenience, or somewhat more or much more convenience with no loss of pain relief, when the device’s AdaptiveStim technology was turned on, compared to a control period when the participants manually adjusted neurostimulation settings using a patient programmer. With AdaptiveStim, study participants reported functional improvements, including improved comfort during position changes (80.3 percent).
Product page: RestoreSensor…