FDA Clears New Neurostimulation System for Chronic Pain

Megan Brooks

August 23, 2022

The US Food and Drug Administration (FDA) has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced today.

The "next generation" of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient's individual therapeutic needs evolve, the manufacturer noted.

"Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs," the company said in a news release.

The system also has therapy settings accessed using a mobile device.

Through their mobile device, patients can access the manufacturer's NeuroSphere Virtual Clinic, which allows them to communicate with their provider and receive remote adjustments to their therapeutic settings as needed.

Game Changer?

The newly approved system has a battery life of up to 10 years, akin to the company's Proclaim XR neurostimulation system for chronic pain. As reported at the time by Medscape Medical News, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pennsylvania, noted in the release that spinal cord stimulation has provided "tremendous relief" for patients with chronic pain.

Falowski added that "with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game-changer" for these patients.

"However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened…because of multiple painful areas and evolving pain," he said.

"Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time," said Falowski.

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