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Home » FDA approves expanded MRI labeling for Abbott Proclaim neurostim

FDA approves expanded MRI labeling for Abbott Proclaim neurostim

January 18, 2024 By Sean Whooley

The Proclaim DRG neurostimulation device. [Image courtesy of Abbott]
Abbott (NYSE: ABT) announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system.

Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine.

Abbott says four out of five people who receive Proclaim DRG stimulation experience significant pain relief and improved quality of life.

The expanded labeling allows patients to receive full-body MRI scans while implanted with the device.

MRI can help assess the progression of CRPS. Having Proclaim DRG allow for MRI scans anywhere in the body (within approved parameters) provides value to patients and radiologists.

Expanded labeling allows for use of Abbott’s system in full-body scans for new and existing patients. Safe scanning of any body part makes it easier to find an imaging center as well. The system also has compatibility with 50cm SlimTip DRG leads.

Dr. Timothy Deer serves as president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia. Deer says expanded MRI capabilities means people no longer need to sacrifice pain relief and quality of life for MRI needs.

“As we continue to work holistically across chronic pain care, we’re 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,” said Pedro Malha, VP, neuromodulation, Abbott.

Filed Under: Food & Drug Administration (FDA), Imaging, Implants, Neurological, Neuromodulation/Neurostimulation, Pain Management, Regulatory/Compliance Tagged With: Abbott, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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