Medtronic Announces Clinical Trial for Neurostimulation Therapy – Implanted Device For Chronic Back and Leg Pain
Posted May 10 2010 11:39pm
We have heard quite a bit about the brain implants but this is the first that I have heard of this technology that will adjust the amount of relief based on the patient’s position. If you have used an IPhone you know what an accelerator and the technology here is similar but a lot more sophisticated since it is implanted.
If a patient changes their mind, the neurostimulator can be turned off. It comes with a control unit about the size of a cell phone. I am just guessing that this is going to be a popular trial for this device as there are so many with chronic back pain.
We are back to my favorite word here again as it uses a proprietary sensor and algorithm to determine the position of the body. Algorithms are not all that bad if they can help relieve pain (grin). The devices already has the European CE Mark for approval. In addition it sends an audit trail of data. BD
MINNEAPOLIS – May 6, 2010 – Medtronic, Inc. (NYSE: MDT) today announced the initiation of a prospective, multi-center, randomized U.S. clinical trial for the RestoreSensorTM 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. The RestoreSensor neurostimulator received CE Mark approval in Europe and is under investigational use in the United States. The U.S. clinical trial will evaluate the benefits of the unique AdaptiveStimTM feature of the RestoreSensor device that uses a cutting-edge, proprietary smart technology for the first time in an implantable medical device for the treatment of chronic pain.
Physicians at ten U.S. medical centers will be enrolling patients in this study. The first implant of a RestoreSensor neurostimulator in the study was performed by David Schultz, M.D., at MAPS Pain Clinic in Minneapolis.
The RestoreSensor neurostimulator also records and stores the frequency of these posture and activity changes. These objective data provide feedback to the clinician to understand whether the patient’s individual stimulation requirements are changing over time.
“Neurostimulation offers patients a therapy that has been clinically proven to provide pain relief, but there is variance in the device settings required to maximize the pain relief and comfort based on a patient’s activity,” said David Schultz, M.D., founder and medical director of MAPS Pain Clinics and MAPS Applied Research Center (MARC) in Minneapolis, and investigator in the RestoreSensor clinical trial. “We are pleased to be involved in the clinical efforts to study a device that could address an unfulfilled need for a neurostimulation system. This device is designed to allow automatic response to changes in position and maintenance of a consistent, optimal level of stimulation for patients.
AdaptiveStim technology uses a proprietary sensor and algorithm that leverage the latest advancements in motion detection technology. Similar to the sensing mechanism used in innovative technologies like automobile airbags and popular 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.