Renata Medical has received the US Food and Drug Administration (FDA) approval for its Minima Growth Stent to treat aortic coarctation and pulmonary artery stenosis.
Minima Growth Stent, the first of its kind, is designed specifically for neonates, infants, and young children.
California-based Renata Medical has designed the stent to re-expand throughout the child’s growth period, supporting the treatment of congenital heart defects.
The FDA has approved the Minima Stent for treating stenosis, or vessel narrowing, in the aorta and pulmonary arteries.
For young patients with these stenoses, the Minima Growth Stent is said to offer a minimally invasive solution that can be expanded as the child grows.
The stent is delivered via a small needle inserted into a vein or artery in the groin or neck like other interventional procedures.
Minima’s design features long, thin struts that allow the stent to be crimped down to less than 2mm in diameter, Renata Medical said.
The proprietary design ensures that the stent can expand to larger sizes while maintaining the necessary force to keep the narrowed vessel open.
Furthermore, the patients who receive the Minima Growth Stent can go home the day after the procedure, and those requiring stent expansion can often be discharged on the same day.
Renata Medical co-founder and CEO Dustin Armer said: “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.”
The FDA approval was based on data from the GROWTH trial. The prospective, multi-centre, non-randomised clinical study evaluated the safety and effectiveness of the Minima Growth Stent in paediatric patients.
GROWTH found that 97.6% of patients experienced effective relief from stenosis, and 100% were free from the need for additional surgical intervention six months after implantation.
Additionally, the study highlighted the stent’s safety profile, with 100% of patients remaining free from major device-related adverse events during the six months.
The Minima Stent System uses advanced Growth Technology designed for long-term effectiveness.
The cardiovascular-focused medical device firm plans to incorporate this foundational technology into its future products.
