Abbott has secured the US Food and Drug Administration (FDA) approval for its new Proclaim Plus spinal cord stimulation (SCS) system to deliver FlexBurst360 therapy.
The US medical device maker developed FlexBurst360 therapy based on its unique BurstDR stimulation that works by mimicking natural patterns of the brain to relieve pain.
It works to relieve pain across up to six areas in the trunk and limbs, and enables programming to adjust the settings as per the patient’s therapeutic needs.
Abbott designed the new Proclaim Plus SCS system to be recharge-free, featuring a battery that can last up to 10 years.
It can be used with its NeuroSphere Virtual Clinic connected care technology, which facilitates secure in-app video chat with physician and remote stimulation settings.
Abbott neuromodulation vice president Pedro Malha 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.
“Our latest development, Proclaim Plus with FlexBurst360 therapy, is yet another testament of that commitment.”
BurstDR is a 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.
In the clinical trials, BurstDR therapy delivered superior pain relief compared to tonic stimulation, and improved the quality of life, and reduced the emotional suffering dur to pain.
Unlike other tonic stimulation technology, which provides a tingling sensation felt by the patient, BurstDR offers pain relief in a sub-sensory range, which is not felt by the patient.
In the trials, 87% of people preferred BurstDR technology, said Abbott.
The company said that its FlexBurst360 therapy, delivered through the Proclaim Plus system, will help physicians identify the lowest effective dose of stimulation for each patient, and adjust the simulation based on evolving pain needs.
In addition, it allows the physicians to control multiple independent BurstDR stimulation areas to provide a wider pain coverage, eliminating the risk of overstimulation, said Abbott.
