Novel Size-Adjustable Pulmonary Valve US Early Feasibility Study: One-Year Outcomes

This US Food and Drug Administration (FDA)-approved prospective, single-arm, multicenter early feasibility study evaluated the Autus Size-Adjustable Valve (ASAV), a surgically implanted, fully synthetic, balloon-expandable pulmonary valve for children requiring pulmonary valve replacement. The biomimetic bileaflet valve has expanded polytetrafluoroethylene leaflets on a 316-L stainless steel frame is manufactured at 12.7 mm internal diameter and can be expanded to 22 mm to match body size and future growth. Eleven patients were enrolled at three centers; median age was 8.2 years and nine were male. Implant diameter was adjusted to 14 to 20 mm. At one year, there was no mortality, thrombus, endocarditis, or device-related adverse events; 10 patients had no pulmonary regurgitation (trivial in one patient). The authors conclude that ASAV showed intact one-year valve function and early safety.