FDA approves balloon-expandable pulmonary valve for children
The Autus valve is widened later with a balloon catheter; six-month study findings cover the first 60 of 62 enrolled patients.
Event / data period: 2026-10-01
Published: · Updated:
The FDA approved the Autus Size-Adjustable Valve for pediatric patients with congenital pulmonary valve disease. A clinician can widen the implanted valve with a balloon catheter as a child grows: its initial diameter can be about 13 millimeters and its expanded size can reach 22 millimeters. The valve does not grow on its own and uses polymer leaflets rather than animal-derived tissue.
The supporting study enrolled 62 children at 12 U.S. sites, but the six-month blood-flow endpoint reported by FDA covered the first 60. Three patients had valve-frame fractures and two had reduced leaflet movement; FDA said these events caused no symptoms. Two patients whose valve performance began to decline as they outgrew the device had it expanded without surgery, though the agency said experience remains limited and longer-term studies continue.
Data
Adjustable valve study in children
Study and device figures cited in the FDA approval.
- Children enrolled
- 62 patients
- 2026-10-01 · Observed
- Patients in six-month results
- 60 patients
- 2026-10-01 · Observed
- U.S. study sites
- 12 sites
- 2026-10-01 · Observed
- Approximate initial diameter
- ≈13 mm
- 2026-10-01 · Observed
- Maximum diameter after expansion
- ≤22 mm
- 2026-10-01 · Observed
- Patients with frame fracture
- 3 patients
- 2026-10-01 · Observed
- Patients with reduced leaflet movement
- 2 patients
- 2026-10-01 · Observed
- Valves expanded without surgery
- 2 valves
- 2026-10-01 · Observed
Methodology
The study enrolled 62 children at 12 U.S. sites; FDA’s six-month blood-flow result concerns the first 60. Three patients had frame fractures and two had reduced leaflet movement, without symptoms from these events. Two valves were expanded without surgery; experience remains limited.
Updated:
Subjects and places
Subject proposals
- HealthSuggested
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