FDA OKs Renata Medical’s Expandable Minima Growth Stent

Renata Medical has received U.S. Food and Drug Administration (FDA) approval for the company’s first-of-its-kind Minima Growth stent tailored to neonates, infants, and young children.
 
The Minima stent re-expands over the course of the patient’s growth period. The approval marks a novel solution in care of young children facing congenital heart defects.
 
The approval covers Minima’s use to treat stenosis in the aorta or pulmonary arteries.
 
It’s delivered through the vein or artery in the groin or neck with a small needle. Minima’s design features struts that allow it to be crimped down to less than 2 mm to access very small veins and arteries. Its proprietary design helps the stent expand to larger sizes while maintaining the force needed to keep the narrowed vessel open.
 
The company said most patients who receive Minima need only one day in the hospital before they can return home. When their stent needs expanding, they can go home on the same day.
 
The company’s GROWTH pivotal trial provided the data needed for FDA approval. 97.6% of patients in the study experienced effective stenosis relief, with all patients free from further surgical intervention at six months after implantation. All patients were also free of major device-related events through six months.
 
Renata said the company plans to leverage its core Growth Technology in their pipeline of innovation.
 
“Renata Medical is honored to partner with those helping children born with congenital heart disease,” said Dustin Armer, co-founder and CEO of Renata Medical. “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.”