CMS Grants NTAP for Renata Medical's Pediatric Minima Stent System

Renata Medical has secured a New Technology Add-on Payment (NTAP) designation from the Centers for Medicare & Medicaid Services (CMS) for its Minima stent system, effective October 1, 2025. NTAP provides additional reimbursement to hospitals adopting new medical technologies early in their market presence, highlighting the Minima stent's impact on improving pediatric patient outcomes. The device received FDA approval in late 2024 and is designed specifically for pediatric patients with congenital heart conditions such as aortic coarctation and pulmonary artery stenosis.

The Minima stent features a proprietary growth technology that allows it to expand as children grow, maintaining vessel patency without repeated interventions. Its delivery through minimally invasive access points and its ability to crimp down to less than 2mm enable less traumatic treatment and shorter hospital stays. Patients typically spend just one day in the hospital post-procedure, with subsequent expansions potentially performed on an outpatient basis.

The CMS's NTAP endorsement, which offers hospitals up to $22,685 in additional reimbursement per case, recognizes the clinical value of Minima for pediatric congenital heart disease management. This reimbursement support addresses a critical need in pediatric cardiology by facilitating access to innovative devices tailored for younger patients with complex cardiovascular conditions.

Renata Medical's CEO highlighted the NTAP decision as a significant advancement for congenital heart centers, emphasizing the policy's role in supporting hospitals in adopting transformative, pediatric-specific cardiac devices. This reimbursement milestone may incentivize broader utilization of the Minima stent, influencing payer strategies and hospital investment decisions in pediatric cardiovascular care technologies.

Overall, the NTAP designation signifies a meaningful progression in aligning reimbursement policies with innovative medical device technology, potentially shaping future regulatory and market frameworks for pediatric cardiovascular interventions in the U.S.