Development of an Implantable Pudendal Nerve Stimulator To Restore Bladder Function in Humans After SCI

Abstract

The goal of this contract is to develop an implantable pudendal nerve stimulator to obtain the FDA approval for a future clinical trial to restore bladder function in human after SCI. During the first year of the contract, we have achieved the following:1. In Cube Labs (subcontractor) has developed the pre-application material for FDA approval of Humanitarian Use Designation (HUD) of the device.2. In Cube labs has designed and manufactured the first prototype of the stimulator, including both software and hardware.3. University of Pittsburgh has tested the first prototype of the stimulator in animal studies. Additional improvements on the first prototype were determined during the animal experiments. We have made significant progress on every items listed in the statement of work (SOW). More details about this years progress can be found in this annual report.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2016
Accession Number
AD1027666

Entities

People

  • Changfeng Tai

Organizations

  • University of Pittsburgh

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Catheterization
  • Contracts
  • Department Of Defense
  • Engineers
  • Graphical User Interface
  • Health Services
  • Intellectual Property
  • Medical Personnel
  • Multiple Sclerosis
  • Nervous System
  • Nervous System Malformations
  • Peripheral Nervous System
  • Personnel Management
  • Power Supplies
  • Spinal Cord
  • Therapy
  • Urinary Tract

Readers

  • Clinical Trial Research.
  • Neurotrauma and Rehabilitation Medicine.