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November 22, 2011

FDA clears Medtronic pain management system

The US Food & Drug Administration (FDA) has approved Medtronic's AdaptiveStim with RestoreSensor neurostimulation system for the management of chronic pain.

The US Food & Drug Administration (FDA) has approved Medtronic’s AdaptiveStim with RestoreSensor neurostimulation system for the management of chronic pain.

The system uses motion sensor technology to provide effective pain relief by automatically adapting stimulation levels to the needs of people with chronic back or leg pain.

It comprises an implantable medical device similar to a pacemaker to hinder pain signals from reaching the brain.

The multicentre, prospective, open-label crossover study randomised 79 study participants 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.

In the study, participants reported functional improvements, such as improved comfort during position changes, when the device’s AdaptiveStim technology was turned on.

Medtronic Neuromodulation division pain and drug delivery therapy businesses vice-president and general manager Julie Foster said the company believes that the AdaptiveStim technology will help to treat pain management.

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