ABBOTT’s Proclaim XR Spinal Cord Stimulator Gets FDA Approval for Chronic Pain Management

Abbott won FDA approval for its Proclaim XR recharge-free neurostimulation system for...

Image: Abbott

Abbott won FDA approval for its Proclaim XR recharge-free neurostimulation system for people living with chronic pain. The neurostimulator can treat chronic pain for up to ten years without requiring a recharge.

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The Proclaim XR platform offers a low dose of Abbott's proprietary BurstDR™ stimulation waveform, which was created based on scientific insights from doctors and research to mimic natural patterns found in the brain. It works by using low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain, reports Abbott.

The neurostimulation system was developed based on positive results from Abbott's BurstDR micrOdosing stimuLation in De-novo patients (BOLD) study. The study showed that all 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).

Image: Abbott

An estimated 50 million people in the United States suffer from chronic pain. Chronic pain affects more American than diabetes, heart disease and cancer combined.

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“For the 50 million people living with chronic pain in the United States this is a new and exciting treatment that is supported with evidence validated by the BOLD study, an established protocol for titrated intermittent dosing to give patients individualized pain relief while using therapy for 6 hours or less per day,” said Timothy Deer, M.D., DABPM, president and chief executive officer of The Spine and Nerve Center of the Virginias in Charleston, W.Va. “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.”

Sam Draper
October 1, 2019

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