Abbott's Proclaim™ XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S.
By Admin | January 09, 2022
Abbott (NYSE: ABT) announced today 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.
"MRIs have increasingly become an important tool helping doctors diagnose an illness or injury. They are particularly important for patients who have certain comorbidities, such as cancer or multiple sclerosis," said Allen W. Burton, M.D., medical director of Abbott's neuromodulation business. "We made it our mission to secure expanded MRI labeling for our spinal cord stimulation devices – both those that were already implanted and those still to be implanted – for the sake of the patients and...(More)
For more info please read, Abbott's Proclaim™ XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S., by PRNewswire