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Stroke rehab device gets FDA breakthrough



Reach Neuro has received a breakthrough device designation from the FDA for its spinal simulation device, Avantis.

The FDA awarded this breakthrough device designation due to Avantis prioritising an important area currently lacking long-term treatment for stroke patients managing upper body paralysis.

By using small electrical impulses delivered to the spinal cord, the Avantis helps to restore shoulder, arm and hand movements. According to Reach Neuro the device can directly restore a patient’s ability to control movement and help alongside physical therapy.

Currently, the device is being tested in a National Institutes of Health (NIH) funded clinical trial. Previous data that was published in the Nature Medicine journal, demonstrated improvements in grip joint and strength.

The device has already shown to make positive impacts towards functional tasks such as using cutlery and lifting objects, however, these effects were not long-term. It is thought that for the device to have longer lasting effects, chronic implantation of the device would likely be required.

Worldwide, stroke is one of the biggest causes of disability and an estimated 100,000 people in the UK have a stroke every year.

Avantis could become a long-term treatment option, which is certainly unique. It allows a new option for treatment in a therapeutic space where early-phase physical therapy intervention predominates.

Reach Neuro’s Avantis has been able to demonstrate how electrically stimulating spinal neurons have been used to treat upper body paralysis for the first time ever.

Heather Rendulic, the first participant in the university-lead clinical study, says: “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.”

Marc Powell, CEO and co-founder of Reach Neuro, says: “We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability.

“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system.”