Mainstay Medical has received approval from the US Food and Drug Administration (FDA) for full-body MRI conditional labelling for its ReActiv8 Restorative Neurostimulation system.
The approval allows all current and future US patients implanted with the device, featuring the standard 45 cm leads, to undergo 1.5T [Tesla] full-body MRI scans safely.
Mainstay said the ReActiv8 FDA MRI Guidelines manual details the specific conditions and safety information for these scans.
The ReActiv8 implantable device is designed to alleviate intractable chronic low back pain (CLBP) in adults, particularly when associated with multifidus muscle dysfunction.
This condition can be identified through imaging or physiological tests in patients who have not found relief through conventional therapies, including pain medications and physical therapy, and who are not suitable candidates for spine surgery.
The device is commercially available in regions including the European Economic Area, Australia, the UK, and now the US.
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Mainstay Medical CEO Jason Hannon said: “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.
“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 2.0W/kg for the rest of the body).
“We look forward to building on this as we seek conditional MRI compatibility in Europe and Australia.”