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Medtronic Initiates RestoreSensor Neurostimulator Clinical Trial

Medtronic had initiated a prospective, multi-center, randomized US clinical trial for the RestoreSensor neurostimulator that adapts therapy to the changing needs of chronic pain patients by responding automatically to changes in body position and activity in an upright position.

Medtronic RestoreSensor neurostimulator received CE mark approval in Europe and is under investigational use in the US.

Medtronic said that the US clinical trial will evaluate the benefits of the AdaptiveStim feature of the RestoreSensor device that uses a smart technology for the in an implantable medical device for the treatment of chronic pain.

Physicians at 10 US medical centers are expected to enroll patients in the study. The first implant of a RestoreSensor neurostimulator in the study was performed by David Schultz at MAPS Pain Clinic in Minneapolis.

Medtronic claimed that the RestoreSensor device with AdaptiveStim technology is the first device to sense a change in body position and automatically optimize the pain therapy settings.

AdaptiveStim technology uses a sensor and algorithm that leverage the latest advancements in motion detection technology. Similar to the sensing mechanism used in technologies like automobile airbags and consumer electronics, the sensing capabilities of the RestoreSensor neurostimulator involve the use of an accelerometer to sense changes in body position.

Once the AdaptiveStim feature is activated, programming parameters based on a patient’s optimal stimulation settings are correlated to certain positions or activity. When the programming is complete, the device is designed to improve pain relief regardless of body position by automatically adjusting the device settings.

Don Deyo, vice president of product development and technology in Neuromodulation business at Medtronic, said: “We are proud to be developing this breakthrough technology that will continue to help patients with chronic pain return to a more full life. We expect the RestoreSensor neurostimulator with cutting-edge AdaptiveStim technology will set a new precedent for using neurostimulation to manage chronic pain.”