FDA Approved Renata Minima Stent for Infants with Congenital Heart Defects
Key Insights
The FDA approved the Renata Minima stent (search) in August 2024 for infants with congenital heart defects (search) affecting pulmonary arteries (search) or the aorta (search).
The Minima stent is designed to expand using a minimally invasive method, reducing the need for multiple invasive surgeries as the child grows.
Cincinnati Children’s (search) was the second institution to implant the stent in March 2022 as part of an early feasibility study.
The Renata Minima stent (search), designed for infants with congenital heart defects (search), received FDA approval in August 2024, marking a significant advancement in pediatric cardiology. This innovative stent addresses conditions where the pulmonary arteries (search), responsible for carrying blood from the heart to the lungs, or the aorta (search), which carries blood to the rest of the body, are too narrow.
Addressing a Critical Unmet Need
Previously, interventional cardiologists had to modify adult stents to fit the tiny vessels of infants, necessitating multiple replacement surgeries as the child grew. The Minima stent overcomes this limitation by offering a device specifically designed for pediatric use that can be expanded as the child matures.
Shabana Shahanavaz, MD, director of the Cardiac Catheterization Laboratory at Cincinnati Children’s (search), who was involved in the multicenter early feasibility study, highlighted the significance of this development. "I have been an interventional cardiologist for 15 years now. In that time, we have never had a stent that has been manufactured specifically to be safe when used in a baby," Shahanavaz said. "This simple technology, once placed in an infant, can be dilated up to an adult size. It’s mind boggling to think we didn’t have that before."
Minimally Invasive Expansion
The Minima stent is implanted using a minimally invasive method, eliminating the need for repeated, invasive surgeries. Cincinnati Children’s (search) was among the first institutions to implant the stent as part of the feasibility study in March 2022.
The early feasibility study that led to the FDA approval was a multicenter trial, demonstrating the safety and efficacy of the Minima stent in a real-world setting.