NTAP approval highlights Minima’s clinical significance and ensures hospital reimbursement for inpatient use beginning October 1, 2025

Renata Medical, a company dedicated to transforming care for children with congenital heart disease, today 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, 2025.

The Minima Stent System is the first and only FDA-approved stent designed specifically 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.

This NTAP approval serves not only as a powerful reimbursement win, but also as a rare and prestigious endorsement of the Minima Stent System’s meaningful impact on patient outcomes. With only a select number of technologies reaching this milestone each year, NTAP reflects the clinical value, innovation, and unmet need Minima addresses for the most vulnerable pediatric patients. It reinforces the importance of continued investment and leadership in congenital heart disease innovation.

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.

“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.”

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

Minima is currently commercially available in the United States.

For additional information, visit www.renatamedical.com.

About Renata Medical

Renata Medical is a privately held medical device company committed to revolutionizing treatment for congenital heart disease. The company’s flagship product, the Minima® Stent System, is the first endovascular stent designed specifically for use in neonates, infants, and young children with vascular stenoses, with the ability to expand to adult dimensions over time.

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NTAP reflects the clinical value, innovation, and unmet need Minima addresses for the most vulnerable pediatric patients.