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. This 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—according to an Abbott press release.
The expanded MRI labelling covers the majority of Proclaim XR patients, providing additional benefits to them and their healthcare providers. It also means patients with a Proclaim XR SCS device—an implantable system designed to allow patients to attain relief from chronic pain of the trunk and limbs—can benefit from higher quality images with faster MRI scan times, the release adds.
The update will benefit existing patients implanted with Proclaim XR SCS systems with Octrode leads too, improving their access to MRI imaging. “Now, more clinicians can utilise MRIs to improve quality of care among a patient population with complex needs,” said Timothy Deer, president and CEO at The Spine and Nerve Centers of the Virginias, serving West Virginia (Charleston, USA). “It allows clinicians to get to the source of a particular issue in less time, and without fear of compromising safety or creating complications.”
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 labelling adds a layer of complexity for both patients and radiologists and, according to the release, they must find an imaging facility willing to modify their workflow and work within the MRI labelling limitations of the patient’s implant.
With this recent labelling update, however, Octrode lead tips can be placed anywhere they are needed along the spine and still be considered ‘MRI-conditional’, which means a patient can undergo MRI scans within the approved outlined conditions. And, 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, according to Abbott.
“The expanded labelling and reduced scan time address two major issues we face with these implantable devices,” said Steven Falowski, neurosurgeon at Neurosurgical Associates of Lancaster (Lancaster, USA). “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, the release adds. 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.
“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, medical director of Abbott’s neuromodulation business. “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.”