Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system.
FDA’s expanded approval covers MRI compatibility for the Proclaim XR spinal cord stimulation (SCS) system with Octrode leads. The new approval 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 Proclaim XR neurostimulation system combines low-energy therapy with a low-dosing protocol to relieve chronic pain while preserving its battery. The platform received FDA approval in September 2019.
According to a news release, the FDA’s expanded labeling covers the majority of Proclaim XR patients, offering higher quality images with faster MRI scan times.
“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,” Abbott Neuromodulation Business Medical Director Dr. Allen W. Burton said in the release. “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 their doctors.”
The new labeling allows for Octrode lead tips to be placed anywhere needed along the spine while remaining “MR Conditional,” meaning patients can undergo MRI scans within the approved conditions. Additionally, radiofrequency energy no longer requires limiting with Proclaim SCS and Octrode devices as long as the MRI is in the normal operating mode.
Proclaim XR SCS device users only need to wait 30 minutes between scan cycles of 30 minutes under the new approval, cutting the MRI scan time by a large margin, Abbott said. Existing patients already implanted with the system will also have improved access to MRI imaging.