The FDA approved the Autus Size-Adjustable Valve on October 1, 2026, for pediatric patients with congenital pulmonary valve disease. It is a surgically implanted pulmonary heart valve that doctors can later widen with a balloon catheter as a child grows. The device does not grow on its own, and the FDA says evidence that later expansion can reduce repeat procedures remains limited.
What the Autus valve does—and what “grows” means
The pulmonary valve controls blood flow from the right side of the heart toward the lungs. Some congenital conditions, including pulmonary stenosis (a narrowed valve) and pulmonary atresia (when the valve does not form normally), can restrict that flow. Treatment may leave a child with pulmonary regurgitation, in which blood leaks backward through the valve; significant leakage can affect the right ventricle and make valve replacement necessary.
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The Autus valve is implanted surgically at a smaller diameter and can later be mechanically widened. The FDA says it can start at approximately 13 mm and be expanded with a balloon catheter to as much as 22 mm. The agency describes the initial size as suitable for a toddler or preschool-aged child and the expanded size as comparable to an adult-sized pulmonary valve. Those dimensions do not guarantee that the device is appropriate for a particular child or will eliminate future procedures.
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1Fix the driver behind crashes, sound loss and screen glitches2Repair Windows errors before they cause bigger problems3Scan for outdated or missing drivers - takes under a minuteThe leaflets—the flaps that open and close—are made of polymeric material rather than animal-derived tissue. The FDA calls Autus the first U.S.-approved valve using polymeric leaflet material for any indication. Its announcement says one-year follow-up suggests the leaflets hold up over time, but that finding does not establish long-term durability or superiority to other materials.
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What the FDA study found
The FDA says 62 pediatric patients enrolled at 12 U.S. sites. In the first 60 patients, six-month results showed acceptable blood-flow performance through the valve and no more than mild leakage. All study patients had a successful procedure. The FDA reported no deaths, blood clots requiring additional treatment, strokes, or other clot-related complications.
The same FDA summary reports three patients with a fracture in the valve frame and two with reduced movement in one leaflet. None of those events caused symptoms in the reported patients. Valve performance began to deteriorate in two children who started to outgrow their valves; both devices were successfully expanded without invasive surgery. The FDA cautions that experience with expansion is limited.
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Edwards Lifesciences, the manufacturer, separately says patients were free from device-related complications through 30 days and reports one-year outcomes among patients who completed that follow-up. Those are manufacturer-reported results; they do not replace the FDA’s six-month cohort summary or resolve the longer-term questions.
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That is a potential benefit, not an established long-term outcome. Because the valve can be enlarged without another open operation in some circumstances, it may help some children avoid or delay repeat surgery as they grow. But the FDA says longer-term studies are continuing to assess whether expansion can maintain valve function and lead to fewer procedures. The available announcement does not establish how many surgeries children will ultimately avoid.
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The FDA approved Autus through the premarket approval (PMA) pathway, which the agency describes as its most stringent type of medical-device marketing application. FDA review considers scientific evidence, including nonclinical and clinical data, for reasonable assurance of safety and effectiveness for the intended use and whether benefits outweigh known risks. Approval does not guarantee an individual result or mean every child is eligible.
How Autus differs from a catheter-delivered pulmonary valve
Autus is a surgically implanted, size-adjustable option. A different approach is Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System, which the FDA describes for selected pediatric and adult patients with severe pulmonary regurgitation involving a native or surgically repaired right ventricular outflow tract, when they are clinically indicated for surgical pulmonary valve replacement. Harmony is delivered through a catheter inserted via a vein in the groin or neck; its valve uses pig heart tissue on a self-expanding nitinol frame.
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These are not interchangeable choices. Harmony has its own indication and anatomy requirements, while Autus is described as a surgical implant that can be enlarged later. Which approach, if either, fits a patient depends on the child’s anatomy, condition, and clinical assessment.
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The FDA announcement does not provide the full approved label, an exact age range, detailed anatomy requirements, or complete contraindications. Families should ask the treating congenital heart team to review the final FDA labeling and explain whether the device is appropriate for the child’s specific condition and anatomy. Useful questions include:
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- Does the child’s diagnosis and anatomy meet the approved indication and selection criteria?
- What alternatives are appropriate, including surgical and catheter-delivered approaches?
- How would the team monitor valve performance, leaflet movement, frame integrity, and the timing of any possible expansion?
- What is known—and still unknown—about durability and future procedures for a child with this clinical profile?
Congenital heart defects affect about 1 in every 100 U.S. births, according to the FDA. Citing the CDC, the agency says pulmonary valve atresia and stenosis together affect around 4,200 U.S. babies each year.
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