Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for the use of its Proclaim XR spinal cord stimulation system with Octrode leads during MRI scans.
As a result of the FDA action, Abbott has added new labeling that lifts MRI restrictions for lead tip location and the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan, according to the company.
Octrode lead tips can now be placed anywhere they are needed along the spine and still be considered MR-conditional, Abbott said. Patients with a Proclaim XR device will only need to wait 30 minutes between scan cycles of 30 minutes, according to the firm.
