FDA approves ‘recharge-free’ neurostimulation device for chronic painOctober 4, 2019
Abbott Laboratories’ Proclaim XR neurostimulation system has been approved by the US Food and Drug Administration (FDA) for chronic pain patients. The battery life of the device can extend up to 10 years, announced the company.
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.
“Abbott’s low-dose and low-energy pain management technology is designed to provide pain relief and improve system longevity, offering patients a life-altering option for pain relief without the hassles of recharging,” the company said in a news release.
The Proclaim XR system allows physicians to identify the lowest effective dose of stimulation customized to each patient, optimizing the longevity of the system while maintaining effective pain relief, Abbott said.
The system was developed based on results from the BOLD study in which all 24 enrolled patients on a low-energy BurstDR dosing programme 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).
“Proclaim XR is a major advancement in spinal cord stimulation, and is an evidence-based therapy that is mobile app-based and features upgradeable software. This means patients won’t need surgery to benefit from future advances in this technology,” said Timothy Deer, MD, president and CEO of The Spine and Nerve Center of the Virginias in Charleston, West Virginia, said in the release.