The FDA warned this week that neurovascular embolization coils may increase image artifact when magnetic resonance angiography imaging is used to image a patient’s aneurysm after coiling.
Physicians use neurovascular embolization coils to treat brain aneurysms and often perform follow-up imaging after the procedure. Traditionally, doctors use digital subtraction angiography to image aneurysms after coiling, but sometimes healthcare providers opt for MRA since it doesn’t expose patients to ionizing radiation.
Data reviewed by the FDA showed that when MRA is performed on patients treated with coils containing 304V stainless steel, the resulting images show larger than expected MR artifact or image voids when compared to other devices.
“In these cases, the reduced quality of the MRA image from increased artifact can result in accurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions,” the U.S. regulatory agency wrote in a letter to providers.
The FDA also noted that most neurovascular embolization coils that are on the market as labeled as magnetic resonance conditional – meaning the device can be safely used in an MR environment.
“The product labeling for neurovascular embolization coils does not currently convey the extent of MRA image artifact caused by the device or the MRA imaging parameters that will yield the lowest amount of image artifact if MRA is used for patient follow-up,” the agency explained.
The FDA recommended that healthcare providers be made aware of the presence of 304V stainless steel in the coil systems typically used by their institutions. The agency said that if providers choose to use MRA for follow-up, they should opt for imaging parameters with the shorter echo times and a high readout bandwidth to minimize image artifact.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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