FDA Clears 'Recharge-Free' Neurostimulation Device for Chronic Pain
The US Food and Drug Administration (FDA) has approved Abbott Laboratories' Proclaim XR neurostimulation system for chronic pain patients. The device has a battery life of up to 10 years, the company announced. The Proclaim XR platform uses the company's proprietary low energy BurstDR stimulation waveform coupled with a low dosing protocol to provide effective pain relief with lower doses of stimulation, which significantly extends the system's battery life.
@sumana The Proclaim XR system was developed based on positive results from the BOLD study in which all 24 enrolled patients on a low-energy BurstDR dosing program saw pain relief with < 6 hours of battery use per day. About half of those patients achieved pain relief with the lowest effective dose (< 2 hours of daily battery use).