FDA Approves Renata Medical Minima Growth Stent for Young Children

August 30, 2024—Renata Medical announced it has received FDA approval for the Minima growth stent, a device tailored for neonates, infants, and young children with congenital heart defects.

According to the company, the minimally invasive Minima stent is approved for aortic or pulmonary stenosis and is designed to be expanded throughout the child’s life.

The stent features long, thin struts that allow it to be crimped down to < 2 mm and the ability to expand to larger sizes while maintaining the necessary force to keep the narrowed vessel open. As noted in the press release, most patients can be discharged home after 1 day in the hospital after receiving the stent and on the same day when their stent needs expanding.

“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,” commented Dustin Armer, Cofounder and CEO of Renata Medical in the press release.

Eason Abbott, Cofounder and Chief Operating Officer of Renata, added that the company hopes to leverage the foundational growth technology in future products.

Renata explained that the FDA approval was based on results from the company’s GROWTH pivotal trial. In this prospective, multicenter, nonrandomized clinical study, investigators evaluated the safety and effectiveness of Minima in neonates, infants, and young children and found the following:

• 97.6% of patients had effective stenosis relief
• 100% were free from additional surgical intervention at 6 months postimplantation
• 100% of patients were free of major device-related adverse events through 6 months

“The approval of the Minima stent is going to have a profound positive effect on our most vulnerable cardiac patients around the world, namely, infants and small children,” added Dr. Evan Zahn, Director of the Congenital Heart Program at Cedars Sinai Medical Center and Chief Medical Officer of Renata Medical, in the company press release. “Having a minimally invasive stent designed specifically to treat these babies and reexpand to keep pace as a child grows is a monumental advancement for our field.”

Renata advised that the Minima stent system is now commercially available in the United States.