The expanded FDA labelling eliminates the restrictions on Proclaim system’s Octrode leads, which are electrically implanted into the target nerves
Abbott Headquarters. (Credit: Abbott.)
Abbott has received the US Food and Drug Administration (FDA) approval for expanded magnetic resonance imaging (MRI) compatibility for Proclaim XR system with Octrode leads.
Proclaim XR is an implantable spinal cord stimulation (SCS) system designed to deploy a low-dosing protocol to relieve chronic pain in the patients’ trunk and limbs.
The new label expansion eliminates the restrictions for MRI lead tip location and the magnitude of radiofrequency power for the normal operating mode of an MRI scan.
According to the company, the expanded approval covers the majority of Proclaim XR system patients and offers additional benefits including high-quality images and faster scan times.
Abbott neuromodulation business medical director Allen Burton said: “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.
“We made it our mission to secure expanded MRI labelling 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 their doctors.”
According to the company, MRI scanners leverage strong magnets and radiofrequency energy to generate detailed images of the body’s internal organs.
The use of MRIs is restricted based on concern over how the magnets and radiofrequency energy could impact the placement of implantable devices.
Abbott said that the expanded labelling allows the Octrode lead tips to be placed anywhere they are required along the spine, while being MR Conditional.
Also, it eliminates the restrictions on the use of radiofrequency energy with Proclaim SCS and Octrode devices, for the MRI scanning in the normal operating mode.
Under the expanded labelling, patients using Proclaim XR SCS device need to wait only 30 minutes between scan cycles of the same time to safely receive an MRI scan.
Furthermore, the label update also benefits existing patients implanted with Proclaim XR SCS Systems with Octrode leads improving their access to MRI, said the company.