Abbott spinal cord stimulator clears FDA hurdle

Abbott’s Proclaim XR spinal cord stimulation system was approved by the FDA for expanded MRI compatibility.

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The labeling lifts restrictions on 60-centimeter Octrode leads, according to a Jan. 4 news release. Under the new labeling, Octrode lead tips can be placed anywhere along the spine and still be considered safe for MRI use.

For patients, the expanded MRI labeling will provide higher quality images with faster MRI scan times.

“The expanded labeling and reduced scan time address two major issues we face with these implantable devices,” neurosurgeon Steven Falowski, MD, said in the release. “By improving the quality of imaging, as well as the experience for both the patient and radiologist, I can now enable more of my existing and new patients to benefit from MRI scans improving their care.”

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

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