California's Renata Medical receives US FDA approval for Minima Growth Stent first-of-its-kind device

image credit- shutterstock

California's Renata Medical announced U.S. Food and Drug Administration (FDA) approval the company’s first-of-its-kind Minima Growth Stent that’s specifically tailored for neonates, infants, and young children, but also designed to be re-expanded over the course of their growth period. This approval marks an advancement in the care of young children facing congenital heart defects.

The FDA approved the Minima Stent for treating vessel narrowing – or stenosis – in the aorta or pulmonary arteries. For young patients presenting with aortic or pulmonary stenosis, the Minima Stent represents a minimally invasive solution that is designed to be expanded over the course of the child’s life. Minima is delivered through the vein or artery in the groin or neck with a small needle. Minima's unique design with long, thin frames – or struts – allow it to be crimped down to < 2mm. This proprietary design also helps the stent expand to larger sizes while maintaining enough force to keep the narrowed vessel open. These features address the challenges of longer recovery times for patients, as well as gaining access to these very small veins and arteries in paediatric patients. This minimally invasive stent is designed specifically to treat paediatric patients and re-expand to keep pace as a child grows.

The Minima Stent System uses foundational Growth Technology designed to provide long-term solutions, and Renata Medical plans to leverage this core technology in their pipeline of innovation. Eason Abbott, Co-Founder and Chief Operating Officer, said, “We built the Minima Stent in collaboration with key opinion leaders to provide another option for patients with congenital heart disease. Together, we hope the stent is the first of many devices that improve the outcomes of our smallest patients.”