Congrats to Proxima CRO medical device client Renata Medical on receiving FDA PMA Approval within a record 180 days!
Congrats to Proxima CRO medical device client Renata Medical on receiving FDA PMA Approval within a record 180 days!
Renata is thrilled to announce the Minima Stent System has received FDA approval for use in the U.S.
Minima is the first and only stent system purposefully designed, tested, and now FDA approved for neonates, infants, and young children. It's designed to be gradually re-expanded to adult sizes, transforming treatment options for pediatric congenital heart disease.
Read the full announcement here >>
About Renata Medical:
Renata Medical, a Delaware corporation, was founded in 2019 with the focus on creating cardiovascular devices for unmet pediatric needs. Renata is committed to innovating, manufacturing, and selling technology that is purposefully created for pediatric patients worldwide.
Connect with us at www.renatamedical.com, LinkedIn, and YouTube.
- Every year, 40,000 children are born with a Congenital Heart Defect (CHD),2 but only 3.8% of approved devices are intentionally designed for neonates, infants, and young children.3
- Minima is the first stent system designed, tested, clinically trialed, and now FDA approved for neonates, infants, and young children. It is also designed to expand to larger sizes over the course of the child’s life.
- Data from the GROWTH Pivotal trial demonstrated that patients who received the Minima stent experienced substantial improvement in vessel size and achieved a 98% predetermined success rate.
