FDA Expands Clearances for Brain Surgery Technologies

The US Food and Drug Administration (FDA) today issued new clearances for patented brain tissue removal technology. The NICO Corporation’s Myriad automated devices are now cleared for use in a wider range of applications thanks to new clearances for specific disease states. A press release from the maker lists “primary and secondary brain tumors, vascular abnormalities and malformations, and intraventricular tumors and cysts,” among the conditions their technology is now approved to treat.

Another technology, BrainPath, received additional clearances, including for high grade gliomas, secondary metastatic tumors, and vascular abnormalities related to stroke. The device is a sheath used to help surgeons safely displace brain matter and maintain visibility of their work while operating.

Both devices are designed to be minimally invasive and to work as an integrated system. The Myriad is an automated device “used for precise resection, suction, clot evacuation and tumor removal in neurosurgery, spinal surgery, ENT and otolaryngology,” according to the company, which claims that over 12,000 surgeries worldwide have already utilized the technology.

The company is confident in the system, with CEO Jim Pearson saying he believes that “it will revolutionize the intracranial neurosurgical market," according to a press release.

The release also quotes Lawrence Dickinson, MD, a neurosurgeon at Pacific Brain and Spine in Castro Valley, California. Dickinson says the system “more efficiently preserves the tumor viability allowing me to culture the cells and develop personalized therapies for my patients,” citing minimized invasiveness and impact on the brain’s anatomy.

The announcement of expanded clearances was made today by the company, which touted the implications for “rapidly growing brain tumor and hemorrhagic stroke markets” that now incorporate over five million patients worldwide.

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