Mainstay Medical this week announced it received FDA approval for MRI labeling on its ReActiv8 restorative neurostimulation system.
The approval allows patients implanted with the 45 cm ReActiv8 leads to be eligible for full-body MRI scans. Patients will be able to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in the ReActiv8 FDA MRI guidelines manual.
“This approval expands the existing safety profile of ReActiv8, broadening access to patients who may need (or develop the need) for MRI imaging after implant,” CEO Jason Hannon said in a news release. “The ReActiv8 MRI labeling is one of the most comprehensive among neurostimulation devices approved for chronic low back pain, with full-body imaging at 1.5T at normal operating mode (maximum specific absorption rate (SAR) of 3.2 W/kg for the head and 2.0 W/kg for the rest of the body). We look forward to building on this as we seek conditional MRI compatibility in Europe and Australia.”
ReActiv8 is an implantable restorative neurostimulation system that treats adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. It has regulatory approval in several geographic areas and is commercially available in Europe, Australia and the U.S.