Pain Medicine News: FDA Approves ‘Low-Dose,’ Recharge-Free Neurostimulation System
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OCTOBER 7, 2019
FDA Approves ‘Low-Dose,’ Recharge-Free Neurostimulation System
The FDA approved the recharge-free neurostimulation system (Proclaim XR, Abbott) for the treatment of chronic pain.
The Proclaim XR platform delivers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which was created “to mimic natural patterns found in the brain,” according to a press release from Abbott. The system delivers mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. The system is promised to operate without recharging for up to 10 years.
The effectiveness of low-energy stimulation is based on finding the lowest effective dose as determined by the treating clinician for selected patients. The neurostimulation system is compatible with Apple devices such as the iPhone, iPad and iPod Touch, and Bluetooth wireless technology.
The system was developed based on positive results from Abbott’s BOLD (BurstDR micrOdosing stimuLation in De-novo patients) study, which showed 100% of 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of battery use per day, while approximately 50% of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use per day). Even at the highest settings, the systems were still in use only 25% of the time. Data from this trial were presented at the annual North American Neuromodulation Society meeting and the International Neuromodulation Society World Congress earlier this year.
“Proclaim XR is a new and differentiated advancement in how we approach chronic pain management, offering a safe and effective nonopioid technology,” said Jacqueline Weisbein, DO, of Napa Valley Orthopaedic Medical Group, in Napa, Calif. “Having access to reliable pain relief—from a system that doesn’t have the hassle of needing to be recharged—is a game changer in helping people live their best lives, free from pain.”
Based on a press release from Abbott.
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