Mainstay Medical has announced that the US Food and Drug Administration (FDA) has approved full-body magnetic resonance imaging (MRI) conditional labelling for the ReActiv8 restorative neurostimulation system—an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP).
According to the company, this approval applies to all current and future ReActiv8 patients in the USA implanted with the current 45cm, commercially available leads.
The approval grants patients implanted with ReActiv8 the ability to undergo 1.5T full-body MRI scans, as per a Mainstay press release. The company also details that 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,” stated Jason Hannon, chief executive officer of Mainstay. “The ReActiv8 MRI labelling 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 3.2W/kg for the head and 2W/kg for the rest of the body). We look forward to building on this as we seek conditional MRI compatibility in Europe and Australia.”
