CMS Approves NTAP for Renata’s Minima Stent System

August 12, 2025—Renata Medical announced that the Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for the company’s Minima stent system under the Inpatient Prospective Payment System for Fiscal Year 2026, effective October 1, 2025.

Under the ruling, CMS has finalized a maximum NTAP reimbursement of $22,685 per case with the Minima.

According to the company, Minima is an FDA-approved stent designed for neonates, infants, and young children with native or post-surgical pulmonary artery stenoses or coarctation of the aorta.

The NTAP designation recognizes Minima as a novel and clinically impactful technology that meets CMS’s stringent cost and clinical criteria, noted Renata.

Minima is commercially available in the United States. On August 28, 2024, the company announced FDA premarket approval for the Minima, which previously received FDA designation as a Breakthrough Device.

Renata stated that CMS granted NTAP approval after conducting a robust cost analysis and public comment period, acknowledging the unique challenges of evaluating pediatric technologies using Medicare claims data. Additionally, CMS recognized that while Medicare-covered pediatric cases are rare, technologies like Minima address complex, high-acuity conditions that justify supplemental inpatient reimbursement.