Cincinnati Children's Implants First EV-ICD in Infant Using 3D Surgical Planning

Event summary

  • Cincinnati Children's implanted an extravascular implantable cardioverter-defibrillator (EV-ICD) in 1-month-old Fletcher St. Jean, the youngest patient to receive the device.
  • The hospital used 3D virtual surgery planning to ensure the Medtronic Aurora EV-ICD™ System could fit safely in the infant's chest cavity.
  • Fletcher weighed approximately 10 pounds when his heart stopped due to idiopathic ventricular fibrillation (IVF).
  • The procedure was performed on June 6, 2025, and Fletcher was discharged six days later.

The big picture

Cincinnati Children's breakthrough demonstrates the potential of advanced surgical planning tools to adapt adult-sized medical devices for pediatric use. This case highlights the growing trend of personalized medicine in cardiology, where institutions are leveraging technology to address critical gaps in pediatric care. The success of this procedure could pave the way for similar innovations in other areas of pediatric medicine.

What we're watching

Technology Adoption
How Cincinnati Children's will expand the use of 3D surgical planning for pediatric cardiac procedures.
Regulatory Approval
Whether Medtronic will seek FDA approval for the EV-ICD device in infants, potentially opening a new market segment.
Long-term Outcomes
The pace at which Fletcher and other pediatric patients will require lead replacements as they grow.

Related topics

Medical Devices