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.

Pedro Malha, vice president of Abbott’s neuromodulation business 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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”