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News > U.S.

'Pied Piper' Tumor Device Receives Breakthrough Status: FDA

  • “There are many tumors that are considered inoperable due to the location of the tumor or the frailty of the patient,

    “There are many tumors that are considered inoperable due to the location of the tumor or the frailty of the patient," said Pediatric Neurosurgeon Barun Brahma. | Photo: Reuters

Published 14 February 2019
Opinion

The device mimics white brain matter, causing tumorous cells to migrate where they can be collected and removed.

Deemed the “Pied Piper” for the unusual way it coaxes tumors out of the brain, a groundbreaking medical device is being streamlined through the system after the U.S. Food and Drug Administration gave the tool “breakthrough status” earlier this month.

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The device, also known as the Tumor Monorail, mimics white brain matter and causes tumorous cells to migrate where they can be collected and removed, researchers from Duke University’s Pratt School of Engineering. According to scientists, the tool is meant to manage the spread of tumors, not completely destroy it, thereby making the disease chronic rather than deathly to the patient.

The tool which resembles a catheter tube is connected to a small reservoir and would essentially be inserted into the skull with the reservoir resting just under the scalp.

Project Leader Nassir Mokarram who also works as a research faculty member at the Department of Biomedical Engineering at Duke University, said, “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.

“Simply by being far away from the mother tumor, the cells are more susceptible to dying anyway, and a neurosurgeon can access the reservoir to empty it when needed,” Mokarram said.

Without FDA approval, the project has only been tested on lab rats, however, after the recent award of “breakthrough” in its FDA case file, the device is that much closer to revolutionizing hundreds of neurological procedures.

A member of the research project, Pediatric Neurosurgeon Barun Brahma, said, “The tumor monorail device is a true game-changer in how we think about treating brain tumors,” said pediatric neurosurgeon Barun Brahma, who was part of the research team.

“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 [inoperable] tumors with a minimal approach,” said Brahma.

In light of the recent FDA status change, researchers say they will now be working with the organization, tasked with proving the device is completely safe for use on human. Although the road ahead will be hard, under the FDA’s wing, the scientists say they will be able to work more efficiently, receiving feedback faster on experimental ideas while addressing any concern they may have along the way.

The project was first proposed by the Atlantan NGO Ian’s Friends Foundation which focuses on curing pediatric brain tumors. Research was also supported by the National Cancer Institute’s EUREKA program and the Marcus Foundation of Atlanta.

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