Renata Medical Secures CMS NTAP Approval for New Minima Stent System

Renata Medical has announced that the US Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the Minima Stent System under the Inpatient Prospective Payment System (IPPS).

The Minima Stent System is the first FDA-approved stent specifically designed for neonates, infants, and young children with native or post-surgical pulmonary artery stenoses or coarctation of the aorta. 

The NTAP designation recognises Minima as a novel medical technology that delivers significant clinical benefits and meets CMS’s criteria for cost-effectiveness and patient impact.

This approval highlights Minima as a solution addressing unmet needs in paediatric cardiology. Only a small number of technologies each year achieve NTAP status, emphasising the device’s role in improving outcomes for the most vulnerable patients.

The NTAP approval reflects CMS’s recognition of the challenges in evaluating paediatric technologies using Medicare claims data and confirms that devices like Minima, which address complex, high-acuity conditions, are deserving of additional support and reimbursement.