Accession Number:

AD1104265

Title:

A Pilot Trial to Assess Implantable Myoelectric Sensors (IMES) to Improve Prosthetic Function for Transhumeral Amputees with Targeted Muscle Reinnervation

Descriptive Note:

Technical Report,01 May 2019,30 Apr 2020

Corporate Author:

Henry M. Jackson Foundation for the Advancement of Military Medicine Bethesda United States

Report Date:

2020-05-01

Pagination or Media Count:

229.0

Abstract:

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.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE