FDA Approves Expanded MRI Compatibility for Emerging Spinal Cord Stimulation Modality

The Food and Drug Administration (FDA) has reportedly approved new labeling that removes limits on lead tip allocation and the amount of radiofrequency power employed with MRI scans in conjunction with the Proclaim XR Spinal Cord Stimulation (SCS) System with Octrode™ leads.

The expanded MRI labeling enables clinicians to place the Octrode lead tips anywhere along the spine without hampering the use of MRI scans for approved conditions, according to Abbott, the manufacturer of the Proclaim XR SCS System. The company said the new labeling also removes restrictions on the use of radiofrequency energy for patients with the Proclaim XR SCS System if the MRI device is in normal operating mode.

There may be increased efficiency and safety as well. While the FDA usually requires radiologists to pause MRIs for 30 to 60 minutes between scan cycles due to potential concerns about radiofrequency energy heating up an implant and damaging surrounding tissue, Abbott noted the expanded MRI labeling allows radiologists to wait only 30 minutes between scan cycles of 30 minutes when assessing patients who have an implanted Proclaim XR SCS System.

“The expanded labeling and reduced scan time address two major issues we face with these implantable devices. By improving the quality of imaging, as well as the experience for both the patient and the radiologist, I can now enable more of my existing and new patients to benefit from MRI scans improving their care,” explained Steven Falowski, M.D., a neurosurgeon who is affiliated with Neurosurgical Associates of Lancaster in Lancaster, Pa.

“Now more clinicians can utilize MRIs to improve quality of care among a patient population with complex needs,” added Timothy Deer, M.D., the president and chief executive officer with the Spine and Nerve Centers of the Virginias in West Virginia. “It allows clinicians to get to the source of a particular issue in less time and without fear of compromising safety or creating complications.”