Abbott Receives FDA Clearance of Expanded MRI Labeling for the Proclaim™ DRG Neurostimulation System

Abbott has received the U.S. FDA approval for expanded MRI labeling for its dorsal root ganglion (DRG) stimulation therapy, the Proclaim™ DRG neurostimulation system, which allows patients to receive full-body MRI scans while implanted with the device.

The Proclaim DRG Neurostimulation System is the only FDA-cleared DRG technology that provides targeted relief to people with complex regional pain syndrome (CRPS) type I and II in the lower limbs by stimulating the DRGs, which are clusters of nerve cells located along the spine. With the expanded MRI labeling, the Proclaim DRG neurostimulation system will offer:

  • Full-body scans for new and existing patients^, providing near and long-term flexibility for their imaging needs
  • Safe scanning of any body part with standard MRI scanners^, making finding an imaging center easier and more straightforward for patients and doctors
  • Compatibility with 50cm SlimTip™ DRG leads

The ability to perform full-body MRI scans with the Proclaim DRG neurostimulation system means that, as physicians, we can ensure that people receive the care they need in a timely manner because they don’t have to find a facility that can accommodate special MRI settings for their device,” said Timothy Deer, M.D., Ph, DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va. “With these expanded MRI capabilities, we no longer have to sacrifice superior pain relief and quality of life outcomes in exchange for MRI needs.”

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