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FDA labels Duke researchers' device to help extract brain tumors a 'breakthrough'

Ravi Bellamkonda's team created a tool that the FDA has now designated a "breakthrough device." It helps surgeons extract brain tumors. | Courtesy of Wikimedia Commons
Ravi Bellamkonda's team created a tool that the FDA has now designated a "breakthrough device." It helps surgeons extract brain tumors. | Courtesy of Wikimedia Commons

A tumor removal tool created at Duke was recently designated a “Breakthrough Device" by the U.S. Food and Drug Administration.

This device—called the "Tumor Monorail"—was designed by the Bellamkonda Lab. It works by mimicking the white matter fibers in the brain to trick tumors into moving to locations more accessible by surgeons. Ravi Bellamkonda, Vinik dean of the Pratt School of Engineering and principal investigator on the project, explained how brain tumors like glioblastoma are normally "very tough to treat."

“In some of these tumors, the survival rate has not changed from the 1960’s, before the war on cancer," Bellamkonda said. "The reason this has been challenging, particularly in brain tumors, is that the tumor does not stay in one place—it is extraordinarily invasive.”

However, this device would stop the spread of the brain cancer, which makes the disease easier to treat, according to a Pratt News article

The FDA designation "Breakthrough" is given to projects that could provide improved treatment options for "life-threatening or irreversibly debilitating conditions," the article stated. Having this designation will fast-track the development, assessment and review of the Tumor Monorail, but "does not mean that the device has been approved for clinical use."

Nassir Mokarram, leader of the project and consulting associate in the department of biomedical engineering, noted that the FDA designation will make the research process moving forward faster and more efficient, Pratt News reported.

“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,” Mokarram said in the article. “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.”

Bellamkonda explained that, for some forms of cancer, a surgeon can excise a few extra millimeters of tissue to ensure that the tumor has been entirely removed. But, in the case of brain tumors, removing a few additional millimeters may result in the patient losing brain function.

After starting the research at Georgia Tech, Bellamkonda and his team have been working for the past five years to engineer a solution to this problem. Bellamkonda noted that the original goal was to stop the tumor from moving along the white matter fibers found in the brain, but added that their focus later shifted to different approach.

“We thought, ‘are we fighting nature? This thing wants to move—is there some way we can exploit its desire to move in a way that’s beneficial to us?’” he said.

The researchers then recreated the brain's fibers in the lab and noticed how readily the tumor cells moved along them.

Based on this observation, they designed the device to use the body’s natural machinery to move a tumor toward the exterior of the brain to a location where a surgeon can more easily remove it, Bellamkonda explained.

“It turns out that not just brain tumor cells, but multiple tumor cells love to move along fiber tracks," he said. "We’ve tested many cell types [such as] breast cancer, prostate cancer, pancreatic cancer, multiple cancer types.”

The device has been tested on rats, and researchers are currently working on making the device safe for humans, according to Pratt News. They aim to have the device approved by the FDA for human trials by the end of 2019.