Abbott proclaims FDA approval of neurostimulator to treat pain in 6 areas at once

A spinal cord stimulation device newly approved in the U.S. one-ups other pain relief devices—or, perhaps, six-ups them—by treating multiple areas of the body at once.

The neurostimulator in question comes from Abbott, which previously reeled in the FDA’s approval for an implant that could be used for up to 10 years without requiring any recharging. Its newest iteration of the technology, dubbed the Proclaim Plus, boasts the same recharge-free battery life, while also expanding the reach of its pain treatments to span up to six areas of the trunk and limbs, the company said in a Tuesday announcement.

The multiuse device is designed to target chronic pain, which affects more than 50 million people in the U.S.—the vast majority of whom report experiencing pain in more than one area of the body, according to Abbott.

Spinal cord stimulators like the Proclaim Plus implant send electrical nudges to the nerves located along the spinal cord. The stimulation is meant to interrupt the way the brain processes pain signals, ideally relieving pain symptoms.

In contrast to other stimulators, Abbott’s version of the technology is able to last up to a decade without recharging because it sends out only mild, periodic pulses to the nerves. The devicemaker claims its low-dose approach is a closer mimic of natural neurological patterns than most alternatives, which offer round-the-clock tonic stimulation. In a study of its BurstDR technology, Abbott said 87% of participants preferred the periodic pulses to the constant tingling sensation produced by standard tonic stimulation tech.

The newly approved Proclaim Plus system introduces Abbott’s FlexBurst360 therapy, which allows physicians to direct the BurstDR stimulation to as many as six independent pain sites. It also guides them in choosing the lowest-possible effective dose for each site—which can be adjusted over time—to reduce the risk of overstimulation.

“With its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game-changer in this space, helping to not only improve a patient’s ability to perform everyday activities but also relieve the emotional suffering that pain can cause,” said Steven Falowski, M.D., a Pennsylvania-based neurosurgeon.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened by pain because of multiple painful areas and evolving pain over time,” Falowski 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.”

Like the previously approved Proclaim XR system, the new model can be used with Abbott’s NeuroSphere virtual clinic platform. The neurostimulation management tech was approved by the FDA in 2020 to help control not only the Proclaim spinal cord stimulators, but also Abbott’s Infinity deep brain stimulator for Parkinson’s disease and essential tremors.

The NeuroSphere app is downloaded onto a patient’s own mobile device—or one provided by Abbott—where it can be used to remotely communicate with care teams, check on the functionality of an implant and receive dosage adjustments as needed. So far, the app is compatible only with Apple devices.