Abbott gains US FDA approval for Proclaim Plus spinal cord stimulation system


Abbott has announced that the US Food and Drug Administration (FDA) has approved its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy. The company describes FlexBurst360 as the next generation of its proprietary BurstDR stimulation, offering pain coverage across up to six areas of the trunk and/or limbs, and enabling programming that can be adjusted as a person’s therapeutic needs evolve.

Designed to fit within a person’s life, the Proclaim Plus SCS system is recharge-free, with a battery that can last up to 10 years, according to an Abbott press release. It can be used with Abbott’s NeuroSphere Virtual Clinic connected care technology, which allows a person to both communicate with a physician through secure in-app video chat and remotely receive stimulation settings in real time regardless of location.

“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 Steven Falowski (Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, USA). “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.”

BurstDR therapy is Abbott’s exclusive stimulation technology that delivers pulses—or bursts—of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain. According to the company, clinical studies have shown that BurstDR technology delivers superior pain relief as compared to tonic stimulation, improves people’s day-to-day life, and reduces the emotional suffering associated with pain. When compared to standard tonic stimulation technology, which provides a constant tingling sensation felt by the patient, Abbott claims 87% of people preferred BurstDR technology, which provides pain relief in a sub-sensory range not felt by the patient.

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 system allows doctors control over multiple independent BurstDR stimulation areas to provide broader pain coverage without overstimulation risk, the release also notes.


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