The FDA today released a safety alert warning of issues with magnetic resonance-guided laser interstitial thermal therapy devices that could result in tissue overheating.
In its warning, the FDA said that it is “evaluating data” that suggest potentially inaccurate MR thermometry information could be displayed during treatment, which could contribute to potential errors in ablation assessment and possible thermal energy spread to surrounding tissue, which could result in unexpected damage.
The federal watchdog said it reviewed medial device reports and literature reports of adverse events, including neurological deficits, increased intracerebral edema or pressure, intracranial bleeding and visual changes, when MRgLITT devices were used to treat intra-cranial lesions.
“Several of these reports note events which required urgent medical and/or surgical intervention, and may have been associated with patient deaths. However, it is unclear at this time, whether an inaccuracy of MR thermometry directly caused or contributed to these events,” the FDA wrote in its warning.
The agency recommended that healthcare providers discuss benefits and risks of the use of such devices with patients and explore alternatives, based on an individual patient basis.
The FDA also advised that all such issues be reported to it in a timely manner for further investigation.
