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CLINICAL OUTCOMES: RESTORESENSOR STUDY SPINAL CORD STIMULATION

RESTORESENSOR CLINICAL STUDY RESULTS

The RestoreSensor™ Clinical Study demonstrates that patients using AdaptiveStim™ experienced improved pain relief with no loss of convenience, or improved convenience with no loss of pain relief, compared with using conventional stimulation.

Physicians reported that position-adaptive stimulation provided added clinical benefit for 88.7%* of patients.

Conclusions

AdaptiveStim is safe and effective in providing pain relief and/or convenience compared with conventional stimulation.

  • Patients reported improved comfort during position changes with this new technology.
  • AdaptiveStim represents an important innovation in spinal cord stimulation therapy.
  • When selecting a spinal cord stimulation system for the treatment of chronic trunk and/or limb pain, the benefits of AdaptiveStim merit serious consideration by clinicians and patients, especially for patients who experience uncomfortable stimulation with position changes during the trial stimulation period.

The RestoreSensor Clinical Study was a prospective, multicenter, open-label, randomised, crossover, 16-week trial. Study details can be found in the Clinical Summary for Advanced Pain Therapy Using Neurostimulation for Chronic Pain.

Access clinical summary and other manuals from the Medtronic Manual Library. Search by the product name (for example, RestoreSensor) or model number (for example, 97714). You may also call 800-961-9055 for a copy of a manual.

See the device/therapy manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events, If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.

*

RestoreSensor® Clinical Study compared AdaptiveStim stimulation to Medtronic conventional stimulation; 88.7% is based on analysis of one of two questions that comprised the primary endpoint of improved convenience and/or better pain relief. Percentage based on respondents who completed the pain relief question.