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
