FDA Approves Low-Dose Chronic Pain Neurostimulation Device

SEPTEMBER 26, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved a new neurostimulation device for the relief of chronic pain.

The Proclaim XR recharge-free neurostimulation system, from Abbott Laboratories, has been granted clearance by the FDA for the treatment of chronic pain. The system provides relieve through a low-dose proprietary BurstDR stimulation waveform, which mimics natural brainwave patterns that change pain signals traveling from the spinal cord to the brain.

The low-dose usage of the decide allows for the system’s battery life to extend up to 10 years without losing benefit.

The system also uses Apple mobile digital devices, as well as Bluetooth wireless technology to help manage pain relief.

Positive results from Abbott’s BurstDR Microdosing Stimulation in De-novo Patients (BOLD) study—presented at the Northern American Neuromodulation Society (NANS) and International Neuromodulation Society (INS) meetings this year—showed 100% of the 24 enrolled patients on a low-energy dosing program experienced pain reliefer with less than 6 hours of battery use daily.

Approximately half those patients achieved pain relief with the lowest effective dose of 2 hours daily.

Currently, about 50 million people in the US are living with chronic pain. The novel capabilities and extended duration of the Proclaim XR system provides a significant benefit for this at-need population, Jacqueline Weisbein, DO, of the Napa Valley Orthopedic Medical Group, said in a statement.

"Proclaim XR is a new and differentiated advancement in how we approach chronic pain management, offering a safe and effective non-opioid technology for up to a decade of pain relief," Weisbein said. "Having access to reliable pain relief—from a system that doesn't have the hassle of needing to be recharged—is a gamechanger in helping people live their best lives, free from pain."

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