FDA approves AdaptiveStim neurostimulation device for chronic back or leg pain treatment

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The US Food and Drug Administration (FDA) has approved Medtronic’s AdaptiveStim with RestoreSensor neurostimulation system, the first and only chronic pain treatment that harnesses motion sensor technology found in smart phones and computer gaming systems to provide effective pain relief and convenience by automatically adapting stimulation levels to the needs of people with chronic back and/or leg pain.

“Medtronic is pleased to introduce AdaptiveStim technology, and we look forward to helping address the many concerns we have heard from physicians and patients about traditional neurostimulation systems,” said Julie Foster, vice president and general manager of the Pain and Drug Delivery Therapy businesses in the Neuromodulation division at Medtronic. “It is our intent that this breakthrough technology will help transform pain management and enable people suffering with chronic pain to feel better and get back to their normal activities.”


Neurostimulation systems consist of an implantable medical device similar to a pacemaker to interrupt pain signals from reaching the brain. The treatment has become a mainstay of chronic pain management; however, a change in body position (e.g., sitting up or lying down) can result in an increase or decrease in the intensity of stimulation as a patient’s spinal cord moves closer or further away from the stimulation site. As a result, patients may need to make frequent manual adjustments to their stimulation levels as they move, using a handheld patient programmer.


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 recognising 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% 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%).

 

The multicenter, prospective, open-label, randomised, crossover study enrolled 79 study participants at 10 US centres. Participants were randomised to receive either stimulation from the RestoreSensor device for six weeks with the AdaptiveStim technology turned on followed by six weeks with AdaptiveStim turned off, or six weeks with AdaptiveStim turned off followed by six weeks with AdaptiveStim turned on. When AdaptiveStim was turned off, participants manually adjusted stimulation levels using a patient programmer.


“This research provides important clinical evidence that demonstrates this innovative, 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,” said David Schultz, founder and medical director of MAPS Pain Clinics and MAPS Applied Research Center (MARC) in Minneapolis, USA, and RestoreSensor clinical trial investigator.

 

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