Michael Hainstock, MD, (left) and Michael Shorofsky, MD
The first Renata Minima stent placement in Virginia marks a milestone for infant cardiac care, now offering an FDA-approved solution specifically designed for the tiniest and most vulnerable patients. UVA Health Children’s pediatric cardiologists Michael Hainstock, MD, and Michael Shorofsky, MD, performed this procedure on a 9-month-old infant with branch pulmonary artery stenosis, providing new hope for families facing rare and complex congenital heart disease.
The Renata Minima stent is the first and only balloon-expandable stent engineered from the ground up for neonates and infants—including those as small as 1.5 kg—suffering from vascular stenosis. Unlike prior solutions that required adapting adult stents for use in tiny vessels, the Minima system arrives pre-mounted on an integrated 4F-equivalent delivery catheter, making it uniquely suited for delicate infant anatomy. “The ease of deliverability was remarkable; navigating the stent through a small, fragile vessel without requiring a long sheath was a game-changer,” said Dr. Hainstock following the procedure.
What sets the Minima stent apart is its ability to grow with the child: after initial implantation, the stent can be gradually expanded with standard off-the-shelf balloons during simple catheter-based procedures as the patient grows—potentially up to adult vessel diameters. This creates a pathway for most children to avoid the repeated open-heart surgeries that have previously defined the standard of care. “For the first time, we have a device that not only serves our smallest and most vulnerable patients but is purpose-built to minimize their surgeries and hospitalizations over a lifetime,” said Dr. Shorofsky.
This UVA Health Children’s case is not just a first for the state, but also a part of an ongoing national post-approval study evaluating safety and real-world outcomes with the Minima system, with Dr. Shorofsky as primary investigator. The patient joins a cohort of infants and children who will be closely followed as evidence grows around the stent’s long-term effectiveness and durability. Enrollment is continuing, and the commitment to collaborative, leading-edge research remains at the center of UVA’s mission.
“Families facing congenital heart disease deserve every tool we can offer. The expandability of this stent means a single intervention today can support a child’s health for years to come, dramatically reducing the number of surgeries over their lifetime,” said Dr. Shorofsky.
The Renata Minima stent’s debut at the University of Virginia is a landmark of innovation for pediatric cardiology, showcasing how new technology can change the lives of children and redefine care for the future. “The Minima stent allows us to treat even the smallest infants with unparalleled precision and safety,” Hainstock said. “Its design made access and deployment far easier than anything we’ve used before.”
Filed Under: Clinical