FDA approves expanded MRI labelling for Abbott’s neurostimulator

The US Food and Drug Administration (FDA) has granted approval of expanded MRI labelling for Abbott’s Proclaim DRG neurostimulation system.

This development allows patients implanted with the device to undergo full-body MRI scans.

The Proclaim DRG system, the only FDA-approved dorsal root ganglion (DRG) stimulation therapy, offers targeted relief for individuals with complex regional pain syndrome (CRPS) types I and II in the lower limbs by DRG stimulation.

The system has been shown to significantly alleviate pain and enhance the quality of life for four out of five patients receiving the therapy.

Abbott neuromodulation vice-president Pedro Malha said: “As we continue to work holistically across chronic pain care, we are excited to see this new MRI expanded indication for our proprietary and unique Dorsal Root Ganglion Stimulation therapy become another valuable tool in the hands of treating physicians helping people get back to living a life on their terms.”

The Proclaim DRG system’s compatibility with 50cm SlimTip DRG further enhances its utility.

In a separate development, Abbott has announced the first global procedures using its new Volt Pulsed Field Ablation (PFA) System for the treatment of patients with atrial fibrillation (AFib).

The company expects US clinical trial approval in the first half of this year, with additional procedures planned across Asia-Pacific and Europe.

First-generation PFA systems often required several ablations in various positions to effectively treat targeted tissue. Abbott’s Volt PFA System overcomes these challenges by combining a balloon-in-basket catheter with its EnSite X EP System, a leading heart mapping system.

Abbott electrophysiology business chief medical officer Christopher Piorkowski said: “With AFib cases expected to rise continuously, Abbott’s Volt PFA System meets a growing demand for a more innovative solution that reduces the patient procedure time and overall hospital stay, getting them back to living a fuller, longer life.”

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• Source: https://www.medicaldevice-network.com/news/fda-expanded-mri-abbotts/