The US Food and Drug Administration (FDA) has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro, Inc), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis.
"We are excited about the FDA's recognition of our technology's potential to change the lives of millions of people living with disability," Marc Powell, PhD, CEO, and co-founder of Reach Neuro, said in a company news release.
"The Breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system," Powell added.
Results of the first-in-human study of the system were published in late February in Nature Medicine.
As reported by Medscape Medical News, investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two chronic post-stroke patients.
In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn't perform without spinal cord stimulation.
The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently — tasks that one patient had not been able to do for 9 years.
"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," study participant Heather Rendulic, said in the news release.
Surprisingly, some improvements were retained up to 1 month after the study, even without stimulation. No serious adverse events were reported.
Nearly three quarters of patients with stroke experience lasting deficits in motor control of their arm and hand, as a result of permanent damage to the brain's ability to send signals to muscles.
The early results with the Avantis system provide "promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke," the study team said in Nature Medicine.
Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, where the technology is currently being tested in a clinical trial funded by the National Institutes of Health.
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Cite this: Megan Brooks. FDA Breakthrough Designation for Spinal Cord Stimulation Device - Medscape - Apr 17, 2023.