Abbott has announced that the US 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 labelling 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 labelling covers the majority of Proclaim XR patients, providing additional benefits to those patients and their health care providers as a result of higher quality images with faster MRI scan times, say Abbott.
Allen Burton, medical director of Abbott’s neuromodulation business, 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.”
With the new labelling, 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.
Steven Falowski, a neurosurgeon at Neurosurgical Associates of Lancaster (Lancaster, USA), added: “The expanded labelling and reduced scan time address two major issues we face with these implantable devices. 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.”
Under the expanded labelling, 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, say Abbott.
Timothy Deer, president and chief executive officer at The Spine and Nerve Centres of the Virginias (Charleston, USA), commented: “Now more clinicians can utilise MRIs to improve quality of care among a patient population with complex needs. It allows clinicians to get to the source of a particular issue in less time and without fear of compromising safety or creating complications.”