Abbott announced that the U.S. Food and Drug Administration (FDA) has approved new expanded magnetic resonance imaging (MRI) compatibility for its Proclaim™ XR Spinal Cord Stimulation (SCS) System with Octrode™ leads. The new labeling 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. The expanded labeling covers the majority of Proclaim XR patients, providing additional benefits to those patients and their health care providers.

Under the expanded MRI labeling, patients with a Proclaim XR SCS device can benefit from higher quality images with faster MRI scan times. MRI scanners use powerful magnets and radiofrequency energy to create detailed images of the inside of the body. Concern over how those magnets and radiofrequency energy could impact placement of implantable devices led to conditions being placed on the use of MRIs when a patient had a particular device.

Restricted MRI labeling adds a layer of complexity on both patients and radiologists. They must find an imaging facility willing to modify their workflow and work within the MRI labeling limitations of the patient's implant. With the new labeling, Octrode lead tips can be placed anywhere they are needed along the spine and still be considered MR Conditional, which means a patient can undergo MRI scans within the approved outlined conditions.

Radiofrequency energy no longer needs to be limited with Proclaim SCS and Octrode devices as long as the MRI is in the normal operating mode. Under the expanded labeling, patients with a Proclaim XR SCS device only need to wait 30 minutes between scan cycles of 30 minutes, allowing them to safely receive an MRI scan in a fraction of the time. If a scan exceeds a certain amount of time without a break, radiofrequency energy used during the scans has the potential to heat up the implanted device, which can damage the surrounding tissue.

In general, the FDA requires radiologists to pause MRIs for anywhere from 30 to 60 minutes between scan cycles for patients with implants. The label update will also benefit existing patients implanted with Proclaim XR SCS Systems with Octrode leads improving their access to MRI imaging.