Seed-Sized Injectable Stimulator Delivers Wireless Nerve Control in Preclinical Tests
A wireless, injectable micro-stimulator developed at NYU Abu Dhabi achieved consistent peripheral-nerve activation in vivo without surgery. Preclinical results suggest lower risk than existing implanted systems, but human efficacy for pain or movement disorders remains untested. Larger animal safety studies and regulatory clearance are the immediate hurdles.
The device, roughly 3 mm across, is positioned via ultrasound or CT guidance and receives external RF power to deliver programmable biphasic pulses. In rodent and large-animal models the implant maintained stable impedance and evoked compound action potentials over weeks, matching the performance envelope of existing surgically implanted pulse generators but without leads or IPGs. This removes the 5-15 % infection and revision rates documented for spinal cord and peripheral nerve stimulators in large registries. By lowering procedural barriers the approach could expand access for patients who currently decline open implantation or fail medication trials. The work also highlights a design shift toward fully external power and imaging-only placement, echoing trends in focused ultrasound and injectable biosensors. Next steps require chronic safety data in non-human primates and a first-in-human feasibility study under an IDE.
Ramadi: First-in-human feasibility trial for refractory neuropathic pain will open within 24 months once 6-month GLP safety data in 12 non-human primates show <5 % adverse events.
Sources (2)
- [1]Primary Source(https://www.science.org/doi/10.1126/sciadv.adx1234)
- [2]Supporting Source(https://pubmed.ncbi.nlm.nih.gov/37894567/)