Renata Medical, a 2020 Rosenman Innovator, has received FDA approval for its Minima Growth Stent, designed specifically for pediatric patients with congenital heart defects. The stent, which treats aortic and pulmonary stenosis, is unique in its ability to expand as the child grows, reducing the need for repeated interventions. Implanted through minimally invasive procedures using small veins or arteries, the stent features ultra-thin struts that can be crimped to less than 2 mm for easier use in newborns and infants.
From the press release:
Renata Medical, a California-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) approval for a new stent specifically designed for pediatric patients with congenital heart defects.
The Minima Growth Stent was built to treat newborns, infants and young children, and then it continues to expand as the patient ages. The FDA’s approval covers both aortic and pulmonary stenosis.
“Renata Medical is honored to partner with those helping children born with congenital heart disease,” Dustin Armer, co-founder and CEO of Renata Medical, said in a statement. “The approval of the Minima Stent is a huge milestone for our company, achieving the goal of providing the first stent designed and approved for small, growing children that are unfortunately some of the most vulnerable and overlooked patients.”