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

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.

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Document Details

Document Type
Technical Report
Publication Date
May 01, 2020
Accession Number
AD1104265

Entities

People

  • Brad M Isaacson
  • Levi J. Hargrove
  • Paul F Pasquina
  • Todd Kuiken

Organizations

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Amputees
  • Anesthesia
  • Assistive Technologies
  • Health Services
  • Medical Personnel
  • Military Medicine
  • Prostheses And Implants
  • Prosthetics
  • Residual Limbs
  • Surgical Amputations
  • Upper Limb Amputations
  • Upper Limb Amputees
  • Upper Limb Prostheses

Readers

  • Clinical Trial Research.
  • Trauma Surgery or Emergency Medicine.