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A new approach to brain cancer treatment has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device designation, which denotes that with no approved products with similar capabilities, the FDA will expedite the device’s development in the hopes that it will one day be available for clinical use.

The device functions by utilizing a thin, fibrous catheter tube fitted with a drug that mimics the brain’s white matter in an external reservoir. The cancerous tissue, drawn to the white matter, gradually moves out of the brain tissue and into the external reservoir. As such, this new technique has been dubbed as the “Pied Piper” or “monorail” approach, since the drug does not directly target the cancer itself but rather redirects it to a more manageable state.

Work on this innovation is being conducted at Duke University, where the Duke team catered their device to managing glioblastoma, one of the most aggressive strains of cancer that starts in the brain. There is no cure for glioblastoma, and palliative therapies currently include surgery, radiation, or chemotherapy. The aggressive nature of this cancer is largely due to the way its shape branches out into long tendrils, affecting a large portion of the brain and making it difficult to remove completely. The median survival rate for adults is 11 to 15 months.

With Duke’s prototype tool, the tumors spread more slowly and they shrank by more than 90%. The device also uses no chemicals or enzymes, rendering it a type of minimalist approach to tumor treatment. Since many brain tumors are inoperable simply due to their location in delicate tissue, this device offers an innovative approach to brain cancer therapy.

Neurological device market research published by iData Research notes that an increasing desire for patients to have low procedure risk and live pain-free is driving the more minimally invasive devices in the neurological device market. Duke’s prototype has high potential in this regard as it has the possibility to relocate tumors from deep in the brain to more manageable places where operations will have less overall danger.

“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,” Nassir Mokarram, Duke biomedical engineering faculty member and leader of the project, said in a press release. “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.”

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For Further Information

More on the neurological device market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Neuromodulation, Neurovascular, Neurosurgical and Monitoring Devices.