Regulatory Science Symposium: Emerging Technologies/Treatments Session 6: Cutting Edge Technologies and Humanitarian Devices (2017)

In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.

Course Syllabus/Topics

Regulatory Pathways for Class III Medical Devices:

  • IDE – PMA
  • HUD – HDE – IRB
  • Custom Device

A Rare But Fatal Problem: Fetal Heart Block:

  • Cause severe fetal bradycardia
  • Can progress to hydrops fetalis
  • No effective treatment other than early delivery
  • Approximately 250 cases per year in USA

Minimally Invasive Fetal Pacemaker and its challeges:

  • Implantation
  • Pacing
  • Survival such as motion, integrity, charging, etc.

Fabrication and Deployment of a Minimally Invasive Fetal Pacemaker:

  • Animation demonstration
  • Details of electronics
  • Charging and monitoring system explained

Current Cardiac Pacing Challenges:

  • Adult Pacing – Intravascular Lead
  • Pediatric Pacing – Epicardial Lead


Accompanying text created by Yelin (David) Hu | Regulatory Science Student Worker |

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.