Reach Neuro’s spinal stimulation device, Avantis, has received a breakthrough device designation from the FDA.
The U.S. Food and Drug Administration (FDA) has granted Reach Neuro’s Avantis platform a breakthrough device designation. The prioritisation will be important in an area lacking long-term treatment for stroke patients managing upper body paralysis.
Avantis uses small electrical impulses delivered to the spinal cord to help restore shoulder, arm, and hand movements. The designation by the FDA addresses an absence of a standard of care for patients with long-term paralysis. According to the Pittsburgh, US-based company, the device can directly restore a patient’s ability to control movement and help alongside physical therapy.
The technology is currently being tested in a National Institutes of Health (NIH) funded clinical trial. Previous data, published in the Nature Medicine journal, demonstrated improvements in grip and joint strength. Improvements in functional tasks, like lifting objects and using cutlery, were also seen although long-term effects will likely require chronic implantation of the device.
According to the Centers for Disease Control and Prevention, nearly 800,000 people per year have a stroke in the US and itis a leading cause of paralysis – affecting around a third of the US paralysis population.
Avantis seems to be a long-term, and unique, treatment option in a therapeutic space where early-phase physical therapy intervention predominates. Reach Neuro’s device represents the first time electrically stimulating spinal neurons have been used to treat upper body paralysis.
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By GlobalData“Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life—it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again,” said Heather Rendulic, the first participant in the university-lead clinical study.
“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” said Marc Powell, Ph.D. CEO andco-founder of Reach Neuro.
“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system.”
