Renata Medical announced today that the FDA has approved the first-of-its-kind minima growth stent specifically designed for newborns, infants and young children.
Newport Beach, California-based Renata designed the stent to expand as the child grows. The company says its approval represents a “groundbreaking advance” in the care of young children with congenital heart defects.
Renata received FDA approval for Minima to treat narrowing of blood vessels – or stenosis – in the aorta or pulmonary arteries. Narrowing can force the heart to work harder. If left untreated, a stenotic aorta or pulmonary artery can lead to heart failure and possibly death.
“Renata Medical is proud to partner with those helping children with congenital heart disease,” said Dustin Armer, co-founder and CEO of Renata Medical. “The approval of the Minima Stent is a major milestone for our company. It means we have achieved our goal of providing the first stent designed and approved for young, growing children, who are unfortunately some of the most vulnerable and overlooked patients.”
More about the Renata Medical Minima Growth Stent
The company says Minima is a minimally invasive solution that expands over a child’s lifetime. The device is inserted with a small needle through the vein or artery in the groin or neck and has a unique design. It features long, thin frames (struts) that allow it to be crimped to less than 2mm.
The design developed by Renata allows the stent to expand to larger sizes while maintaining enough strength to keep the narrowed vessel open. Therefore, patients who receive Minima only need to stay in the hospital for one day before they can go home. If the stent needs to be expanded, they can go home the same day.
Clinical results for Minima showed effective relief of stenosis in 97.6%. All patients studied did not require further surgical interventions 6 months after implantation. Safety was also shown to be high, with 100% of patients reporting no serious device-related adverse events within six months.
As of today, the company’s stent is commercially available in the United States
“The approval of the Minima Stent will have a huge positive impact on our most vulnerable heart patients around the world, namely infants and young children,” said Evan Zahn, M.D., director of the Congenital Heart Program at Cedars Sinai Medical Center and chief medical officer at Renata Medical. “Having a minimally invasive stent that is specifically designed to treat these babies and can keep pace with the child as they grow is a tremendous advancement for our field.”
