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August 24, 2022

Abbott receives US FDA approval for Proclaim Plus SCS system

The Proclaim Plus SCS system can be used with the company’s NeuroSphere Virtual Clinic connected care technology.

Abbott has received approval from the US Food and Drug Administration (FDA) for its new Proclaim Plus spinal cord stimulation (SCS) system with FlexBurst360 therapy.

The FlexBurst360 therapy is the latest generation of the company’s proprietary BurstDR stimulation, which relieves pain across up to six areas of the trunk and/or limbs.

It has programming that can be adjusted according to a person’s therapeutic needs.

The recharge-free Proclaim Plus SCS system has been designed to fit within a person’s life and features a battery that can last up to ten years.

The system can be used with the company’s NeuroSphere Virtual Clinic connected care technology, which enables secure in-app video chat with physicians and remote stimulation settings in real-time, regardless of location.

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.”

The company’s exclusive stimulation technology, BurstDR therapy delivers pulses, or bursts, of mild electrical energy to change pain signals as they travel from the spinal cord to the brain.

In clinical trials, the technology provided superior pain relief compared to tonic stimulation.

It also improved patients’ life quality and reduced the emotional suffering related to pain.

Abbott stated that the BurstDR technology offers pain relief in a sub-sensory range, which is not felt by the patient.

It also noted that the FlexBurst360 therapy will allow physicians to identify the lowest effective dose of stimulation for each patient and adjust the stimulation depending on evolving pain needs.

The Proclaim Plus system also allows physicians to control multiple independent BurstDR stimulation areas, providing wide pain coverage while eliminating the risk of overstimulation.

Recently, Abbott reported data from a new study showing that two blood-based biomarkers measured using its tests were able to predict a patient’s recovery from traumatic brain injury (TBI).

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