The pivotal study included 62 children at 12 U.S. sites, according to MedTech Dive. MedPage Today reported that participants had no device-related complications through 30 days and no valve reinterventions through six months. MedTech Dive also reported three valve-frame fractures and reduced movement in one leaflet in two patients; neither type of event caused symptoms.
Long-term durability remains an open question. A sponsored ClickOnDetroit report says researchers are still assessing the leaflet material and describes greater durability as a hope, not a demonstrated outcome.
What one-year follow-up shows
The FDA’s approval review reported that all 51 patients in its one-year effectiveness analysis met the stated criteria for right ventricular outflow tract mean gradient and pulmonary regurgitation. The analysis also reported no AUTUS valve reinterventions, excluding expansions to address prosthesis-patient mismatch, according to the FDA review. That endpoint differs from the reported six-month result and does not establish long-term durability. An FDA-hosted study document lists one-month follow-up for 62 patients, six-month follow-up for 60 and one-year follow-up for 51; it says ongoing follow-up will assess durability and post-implant size adjustments. The FDA-filed instructions for use also say that the safety and effectiveness of post-implant expansion have not been established and clinical data on those procedures are limited.
The device and the treatment challenge
The FDA approved the AUTUS Size-Adjustable Valve on October 1, 2026, describing it as the first valve designed to be enlarged after implantation as a child grows, according to the agency. The valve is surgically implanted and can later be expanded through a catheter procedure, according to Edwards Lifesciences. The company’s product information says it is intended for eligible pediatric patients weighing at least 10 kilograms. A distinct earlier option, the Medtronic Melody transcatheter pulmonary valve, received FDA approval in January 2010 and was the first transcatheter heart valve allowed for use in the United States, according to Cardiovascular Business.
A child can outgrow a fixed-diameter replacement valve, which can contribute to further operations. A 2023 review in Bioengineering & Translational Medicine describes growth-related size mismatch as a challenge with current pulmonary valve prosthetics and says repeat operations are common, particularly for very young patients.
The AUTUS valve uses synthetic polytetrafluoroethylene, or PTFE, leaflets rather than biological tissue, according to the sponsored ClickOnDetroit account and Edwards Lifesciences’ product information. Edwards describes the design as a bileaflet valve made with ePTFE membrane.
The Michigan implantation and FDA review
Before approval, a six-year-old child from Michigan received the valve at C.S. Mott Children’s Hospital. Michigan Medicine reported that the August operation was the first implantation in the Continued Access study, which allowed children to receive the device while the FDA reviewed pivotal-trial results. Cardiovascular Business also reported that Mott performed the first U.S. implant.
Mott enrolled the pivotal study’s final patient in the spring, according to Michigan Medicine. The sponsored ClickOnDetroit report identifies Jennifer Romano as the pivotal trial’s primary site investigator and one of three national principal investigators for the post-approval study. These accounts describe the hospital’s role and the study process; they do not establish the valve’s long-term performance.
Another experimental approach
A separate project from CHOC and UC Irvine is developing the experimental IRIS valve for patients weighing 8 to 10 kilograms. The device has a 12-millimeter minimum diameter and is designed to expand to 20 millimeters. It has been implanted in animal models and widened from 12 to 16 millimeters; further design and materials work, bench testing and human studies were described as potential next steps in the CHOC account.
