Brain-Tumor Extracting Device Gains FDA Approval

The tool that migrates tumors safely out of the brain has been designated as a "breakthrough device" by the FDA.

Researchers at Duke University have developed an innovative brain tumor extracting technology called the Tumor Monorail.

The novel biomedical tool has been referred to as a "Pied Piper" device by the university as it essentially functions by tricking aggressive brain tumors into migrating into an external container, saving the brain from their effects.

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A “breakthrough device"

The technology has now gained approval by the U.S. Food and Drug Administration (FDA) and has been designated a “breakthrough device." This status means that the FDA aims to expedite the development of the tool; however, it is not yet approved for clinical use.

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The device functions by mimicking the physical properties of the brain’s white matter leading tumors to migrate toward the exterior of the brain. Once there, the cells can be safely removed. 

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“The tumor monorail device is a true game-changer in how we think about treating brain tumors,” said Barun Brahma, a neurosurgeon at Children’s Healthcare of Atlanta, who has been a member of the research team since the beginning. 

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“There are many tumors that are considered inoperable due to the location of the tumor or the frailty of the patient. This device affords clinicians the ability to surgically treat these tumors with a minimal approach.”

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The device does not kill the tumors, but it makes them manageable, ensuring that a brain tumor no longer means a death sentence.

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The initial study for the device began in 2014 and since then has been successfully replicated in rat test subjects. The researchers have also been working on redesigning it to make it ideal for human use.

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“What’s most important is that the tumor is spreading in a controlled way through our device to a reservoir, and away from the mother tumor, rather than through the healthy brain tissue,” said Nassir Mokarram, a research faculty member in the Department of Biomedical Engineering at Duke University and leader of the project.

Safe for human use

The researchers have already upgraded the device making it out of a long-lasting material that is well tolerated by the human body and have made other changes such as removing a once toxic gel. The team is now busy at work attempting to prove the device is finally safe for human use.

“The most exciting part about this designation is that it gives us the opportunity to look at the FDA as a partner rather than a reviewer,” said Mokarram.

“The task before us is to prove that the device does not pose a risk to human patients, which is an extremely complicated process. With direct access to the FDA reviewers, we can get more efficient, faster feedback on our experimental ideas to make sure we’re addressing all of their concerns from the very start.”

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