A Pilot Trial to Assess Implantable Myoelectric Sensors (IMES) to Improve Prosthetic Function for Transhumeral Amputees with Targeted Muscle Reinnervation
Technical Report,01 May 2019,30 Apr 2020
Henry M. Jackson Foundation for the Advancement of Military Medicine Bethesda United States
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The overall project goal is to investigate the functional performance of transhumeral amputees who have received targeted muscle reinnervation with EMG signals measured intramuscularly using a fully wireless implant. This year we fabricated the clinical implant and base-station units and performed testing required to submit for an investigational device exemption to the FDA through the early feasibility study mechanism. The FDA responded with a request for additional information with regards to biocompatibility. We have prepared a supplementary test plan and submitted it to the FDA for additional feedback.
- Medicine and Medical Research