Abbott MRI Labeling OK’d for Spinal Stimulator

FDA has approved expanded Magnetic Resonance Imaging (MRI) labeling for Abbott’s Eterna spinal cord stimulation (SCS) system to include new leads that are magnetic resonance (MR)-conditional. Abbott says the expanded labeling “means people with chronic pain can undergo MRI scans within the approved outlined conditions and have a wider selection of lead options for full-body scans.”

Abbott says recent findings from a study the company conducted show that 93% of surgeons consider MRI accessibility an important to essential factor when determining the best SCS system for their patients. “Restrictions for MRI labeling often pose challenges for doctors when it comes to selecting the right treatment approach for their patients, including the need to have access to a range of MR-conditional leads, which are thin wires that deliver low-energy pulses to the nerves along the spine to disrupt pain,” it says.