FDA Approves Abbott & #039;s & #039;Low Dose & #039; Neurostimulation Device for Chronic Pain

Chronic pain patients in the United States now have a new treatment option. FDA has approved Abbott’s Proclaim XR recharge-free neurostimulation system for people living with chronic pain. The Proclaim XR platform offers a low dose of Abbott's BurstDR stimulation waveform, which was created based on scientific insights from doctors and research to mimic natural patterns found in the brain, the company said. It works by using low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. Abbott said the delivery of lower doses of spinal cord stimulation helps extend the system's battery life, allowing people to experience pain relief, without the hassle of recharging, for up to 10 years. The company’s low-energy stimulation is based on finding the lowest effective dose as determined by the treating clinician for select patients. It delivers BurstDR stimulation intermittently, at low energy levels, while allowing people to experience the same level of pain relief. Proclaim XR also uses Apple mobile digital devices and Bluetooth wireless technology to help patients discreetly manage pain, Abbott noted. The system was developed based on positive results from Abbott's BurstDR micrOdosing stimuLation in De-novo patients (BOLD) 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 about 50% ...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news