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Medtronic receives FDA approval for neurostimulator device to treat pain
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The U.S. Food and Drug Administration has granted Medtronic approval to market its RestoreUltra neurostimulation system as a treatment for chronic, intractable pain of the trunk, limbs or both, the company announced in a press release.
This device is a 16-electrode rechargeable neurostimulator that features the unique patient programmer used with the RestoreUltra system, which allows patients control over their therapy. In addition, the neurostimulator allows patients who use medium stimulation settings to go at least 2 weeks before needing to recharge the device.
The patient programmer also includes a new feature called TargetmyStim, which allows patients to make appropriate and immediate adjustments to their stimulation to address normal fluctuations in pain, including changing pain patterns. Patients can additionally fine-tune their stimulation to specific spinal cord sites and increase or decrease the intensity of the electrical impulses, according to the release.
Results from the largest multicenter, randomized, controlled trial of neurostimulation therapy were recently published online by the journal Pain. The Medtronic-sponsored study, known as PROCESS (the PROspective randomized Controlled trial of the Effectiveness of Spinal cord Stimulation), compared neurostimulation therapy plus conventional medical management to conventional medical management alone for treating chronic neuropathic back and leg pain for more than 6 months.
Investigators found that, in the intention-to-treat analysis at 6 months, 24 spinal cord stimulation patients (48%) and four conventionally treated patients (9%; P < .001) achieved the primary outcome: 50% or better pain relief in the legs.
"Compared with the [conventionally treated] group, the [spinal cord stimulation] group experienced improved leg and back pain relief, quality of life and functional capacity, as well as greater treatment satisfaction," the study authors reported.
Between 6 and 12 months follow-up, five spinal cord stimulation patients crossed over to conventional treatment, but 32 conventionally treated patients crossed over to treatment with spinal cord stimulation, according to the study.
At 12 months follow-up, 27 spinal cord stimulation patients (32%) experienced device-related complications, the authors noted.
The RestoreUltra neurostimulation system is indicated to manage chronic, intractable pain in the trunk and/or limbs, including unilateral or bilateral pain. The device is currently available in Europe. Medtronic plans to begin making it available in the United States by the end of February, the release said.
Neurostimulation uses an implantable medical device to deliver electrical pulses to the epidural space in order to prevent pain signals traveling through the nervous system from reaching the brain.
The RestoreUltra neurostimulator is smaller than a pocket watch and is typically implanted subcutaneously at the abdomen. The device is connected to flexible leads, which deliver the electrical pulses.
For more information:
- Kumara K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:179-188.