Abbott (NYSE:ABT) announced today that the FDA approved its new Proclaim Plus spinal cord stimulation (SCS) system with FlexBurst360.
The FlexBurst360 therapy is the next generation of Abbott’s proprietary BurstDR stimulation. Abbott designed it to provide pain coverage across up to six areas of the trunk and/or limbs. It has programming that adjusts as a person’s therapeutic needs evolve.
Proclaim Plus SCS is a recharge-free system with a battery that can last up to 10 years, according to a news release. It can be used with Abbott’s NeuroSphere Virtual Clinic connected care technology for communicating with a physician through secure in-app video chat and remotely receiving stimulation settings in real-time regardless of location.
More about Abbott’s next-gen spinal cord stimulation system
Abbott’s BurstDR stimulation technology delivers pulses, or bursts, of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain. The company said clinical studies demonstrated superior pain relief with BurstDR compared to tonic stimulation, plus the improvement of day-to-day life and reduced emotional suffering associated with pain.
“Spinal cord stimulation has provided tremendous relief for patients suffering from chronic pain. 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 Dr. Steven Falowski of the Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, Pa. “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. 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.”
Physicians using FlexBurst360 on the Proclaim Plus system can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs. The system allows doctors control over multiple independent BurstDR stimulation areas to provide broader pain coverage without overstimulation risk, Abbott said.
“At Abbott, we are deeply committed to advancing the field of neurostimulation, thus helping people address the challenges they face while managing their chronic pain,” said Pedro Malha, VP, neuromodulation. “Our latest development, Proclaim Plus with FlexBurst360 therapy, is yet another testament of that commitment.”