Renata Medical announced today that CMS granted a New Technology Add-on Payment (NTAP) for its Minima stent system.
NTAP provides additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. It goes into effect on Oct. 1, 2025. The company said the reimbursement win serves as an endorsement of its Minima system’s impact on patient outcomes.
Newport Beach, California-based Renata picked up FDA approval for the first-of-its-kind stent last fall. The company designed the stent to re-expand over the course of the child’s growth period. Minima’s growth technology supports aortic coarctation and pulmonary artery stenosis relief to re-expand as the patient grows. Delivered through the vein or artery in the groin or neck with a small needle, the device has a unique design. It features long, thin frames (struts), allowing crimping down to less than 2mm.
Renata’s proprietary design helps the stent expand to larger sizes while maintaining enough force to keep the narrowed vessel open. As a result, patients receiving Minima only need one day in the hospital before they can return home. When the stent needs expanding, they may go home the same day.
The company said CMS’ decision reflects the value of Minima for the most vulnerable pediatric patients. The maximum NTAP reimbursement totals $22,685 per case.
“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.”
