Renata Medical secures CMS reimbursement boost for pediatric stent innovation
Business Insight Digest Team
Business Insight Digest Team provides cutting-edge analysis and insights in technology and innovation.
Renata Medical announced that the US Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for its Minima stent system.
NTAP offers additional reimbursement to hospitals for adopting designated new medical technologies in their initial years on the market.
The policy takes effect on 1 October 2025. Renata said the decision highlights Minima’s positive impact on patient outcomes. The Newport Beach, California-based company received FDA approval for the first-of-its-kind stent last autumn.
Minima is designed to expand gradually as a child grows, addressing aortic coarctation and pulmonary artery stenosis. The device can be delivered via vein or artery access in the groin or neck using a small needle. It features long, thin struts that allow it to be crimped to under 2mm in diameter. The stent can expand to larger sizes while retaining sufficient force to keep the vessel open.
Patients typically spend only one day in hospital after initial implantation. When expansion is needed, procedures often allow same-day discharge. CMS’ NTAP decision supports hospitals in adopting Minima for vulnerable pediatric patients. The maximum reimbursement under the NTAP programme is set at $22,685 per case.
CEO Dustin Armer called the approval a major milestone for congenital heart centres and their patients. He said Minima was created to meet the urgent need for pediatric-specific solutions in congenital heart disease.