Renata Medical Scores Medicare Win for Minima Stent System

Renata Medical announced that the Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for the Minima stent system under the Inpatient Prospective Payment System (IPPS) for fiscal year 2026, effective October 1.

Minima is the first and only U.S. Food and Drug Administration (FDA)-approved stent designed for neonates, infants, and young children with post-surgical pulmonary artery stenoses or coarctation of the aorta. The NTAP designation recognizes the tech as a novel, clinically impactful technology that meets CMS’ cost and clinical criteria.

The NTAP approval was awarded after a robust cost analysis and public comment period, acknowledging the challenges of evaluating pediatric technologies using Medicare claims data.

Under the ruling, CMS has finalized a maximum NTAP reimbursement of $22,685 per case. The approval follows Minima’s FDA premarket approval (PMA) on August 28, 2024, and its prior designation as a Breakthrough Device. CMS recognized that while Medicare-covered pediatric cases are rare, technologies like Minima address complex, high-acuity conditions that justify supplemental inpatient reimbursement.

“This NTAP approval marks a major milestone for congenital heart centers and their patients,” said Dustin Armer, CEO of Renata Medical. “Minima was designed to meet the urgent need for pediatric-specific solutions in congenital heart disease, and this policy change ensures that hospitals are supported in adopting this life-saving technology.”