FDA grants breakthrough designation to vagus nerve stimulation device
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The FDA has approved breakthrough device designation for a novel neuroimmune modulation platform for those with relapsing-remitting multiple sclerosis, according to the manufacturer.
According to a release by SetPoint Medical, breakthrough designation will enable pending priority regulatory review with the FDA, while allowing the company to support reimbursement and patient access upon approval of its technology by the regulatory body.
The FDA’s decision on breakthrough designation was based on evidence demonstrating that SetPoint’s treatment may potentially reduce demyelination and promote remyelination, according to the release.
The integrated neurostimulation device utilizes precise vagus nerve stimulation through a small incision made on the left side of the neck during an outpatient procedure. The device is then programmed to automatically deliver therapy on a preset schedule by stimulating the nerve once daily.
“The ability to promote remyelination and restore function is a major unmet clinical need for patients living with MS,” SetPoint Medical CEO Murthy V. Simhambhatla, PhD, told Healio in an email. “This designation is a significant milestone for our MS program as it enables interactive communication and priority regulatory review with the FDA and highlights the platform potential of SetPoint’s device in bringing new therapies to treat multiple chronic conditions."