Risk of Tissue Overheating with Some MR Devices: FDA

FDA has written to healthcare providers that it is evaluating data suggesting that potentially inaccurate magnetic resonance thermometry information can be displayed during treatment with magnetic resonance-guided laser interstitial thermal therapy devices that are commonly used in neurosurgical procedures. The agency letter says the devices also may not account for the thermal spread of energy to the surrounding tissue (as the target ablation area returns to its baseline temperature), which may result in an underestimation of thermal damage.

The letter says FDA has reviewed medical device reports and literature reports that describe adverse events such as neurological deficits, increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes when the devices were used to treat intra-cranial lesions.

The letter contains recommendations for healthcare providers.