Newport Beach, California-based Renata picked up FDA approval for the first-of-its-kind stent last week. The company designed the stent to re-expand over the course of the child’s growth period.
“Today marks the beginning of something special,” said Dr. Darren Berman, director of congenital interventional catheterization at Children’s Hospital Los Angeles. “With the very recent FDA approval of Renata Medical’s Minima Stent, we now have a stent specifically designed to treat some of the most common congenital heart defects in our youngest patients.
“We implanted the first commercially available Minima Stent in a 2-year-old child with severe branch pulmonary artery stenosis. The procedure went smoothly, and she went home the next day.”
Minima’s growth technology supports aortic coarctation and pulmonary artery stenosis relief to re-expand as the patient grows. Delivered through the vein or artery in the groin or neck with a small needle, the device has a unique design. It features long, thin frames (struts), allowing crimping down to less than 2mm.
Renata’s proprietary design helps the stent expand to larger sizes while maintaining enough force to keep the narrowed vessel open. As a result, patients receiving Minima only need one day in the hospital before they can return home. When the stent needs expanding, they may go home the same day.
“Successfully implanting the first commercial Minima Growth Stent is a monumental achievement for our company. This milestone reflects our commitment to advancing medical technology and improving patient lives,” said Dustin Armer, CEO of Renata Medical. “We are excited to see the positive outcomes this stent will bring to the medical community and the patients we serve.”
