FDA Approves First Expandable Pulmonary Valve for Kids

AUTUS Size-Adjustable ValveWhat to know

30-second read

For Cardiothoracic Surgery · Pediatrics · Cardiology

Who

Children 18 months to 16 years needing a first surgical pulmonary valve replacement for congenital heart disease (e.g. tetralogy of Fallot, pulmonary atresia, truncus arteriosus).

What it does

A surgically implanted pulmonary valve that can later be widened in place by a transcatheter balloon procedure as the child grows, instead of another open-heart operation.

Evidence

Pivotal trial, 62 children at 12 U.S. sites: 100% free of device-related complications at 30 days; no valve reinterventions through 6 months; consistent at 1 year.

What’s different

First FDA-approved valve designed for in-place expansion (13 mm at implant to 22 mm, adult-sized) and the first artificial heart valve with synthetic leaflets, not animal tissue.

Key consideration

Durability beyond 1 year and performance after repeated balloon expansions are not yet established; follow-up continues annually through 10 years.

Availability

FDA approved 1 October 2026. Rollout beyond the pivotal and continued-access sites, and pricing, not yet announced by Edwards.

Practice impactConsider for new surgical candidates

A genuine option for toddlers facing their first pulmonary valve replacement, potentially meaning fewer open-heart operations over childhood. It does not replace Melody or Harmony for patients who already need a catheter-based fix.

Read the full physician analysis

Full analysis · 10 min readEdwards Lifesciences FDA approval announcement · Autus Valve Pivotal Study (NCT05006404)

The U.S. Food and Drug Administration approved the AUTUS Size-Adjustable Valve on 1 October 2026, the first surgical pulmonary valve built to be widened in place as a child grows rather than explanted and replaced in a second or third open-heart operation. Edwards Lifesciences, which acquired developer Autus Valve Technologies in February 2026, says the valve is also the first FDA-approved artificial heart valve with synthetic leaflets instead of animal-derived tissue.

A valve meant to be reopened, not replaced

Congenital heart disease affects more than 40,000 U.S. births a year, and roughly 20% of those children have a congenital pulmonary valve anomaly — more than 7,000 births annually — most often as part of a repair for tetralogy of Fallot, pulmonary atresia, truncus arteriosus or another right ventricular outflow tract (RVOT) defect. The standard problem these children's surgeons have never solved: a valve sized for an 18-month-old is, by definition, too small for a 10-year-old. Every implanted valve or conduit a toddler receives is a valve that child will outgrow, and outgrowing it has meant another sternotomy, another bypass run, another valve.

AUTUS is Edwards’ attempt to break that cycle at the point where it starts — the first operation, not a later catheter-based fix. It is implanted surgically, as small as 13 mm in diameter, suitable for a toddler or preschool-age child. As the child grows, a congenital interventional cardiologist can widen the same valve in place, threading a balloon catheter to the implant site and expanding the frame, eventually up to 22 mm, roughly the diameter of an adult pulmonary valve. The company and several of the surgeons who ran its pivotal trial describe the goal plainly: one valve for a childhood, not three.

How a surgical valve gets bigger without surgery

The first intervention is unavoidably a full surgical implant — cardiopulmonary bypass, a sternotomy, the valve sewn into the RVOT exactly as any other surgical pulmonary valve would be. What changes is everything after that. Edwards says that when the child's anatomy has outgrown the as-implanted size, a catheterization-lab team can enlarge the valve's frame with a balloon rather than send the patient back to the operating room. The company has not yet published how many expansion procedures a single valve is expected to tolerate over a childhood, what sedation or anesthesia the expansion itself requires, or at what intervals a typical child would need one — those are questions the Continued Access Study and the pivotal trial’s extended follow-up are designed to answer over time, not facts established by this approval.

The leaflet material is a separate first. Every other FDA-approved heart valve — mechanical valves aside — uses tissue from an animal source: bovine pericardium, porcine pericardium or a processed bovine jugular vein. AUTUS uses a polymeric (synthetic) leaflet instead, which the company frames as a durability play: animal tissue calcifies and degenerates over years, a particular problem in a valve that will sit in a growing child for a decade or more. Whether the polymer actually outlasts tissue in this application is, like the expansion question, something only years of follow-up will show; the pivotal trial’s longest reported outcomes run to one year.

What the 62-child pivotal trial showed

The Autus Valve Pivotal Study (NCT05006404) began enrolling in February 2024 as a prospective, single-arm, multicenter trial of 62 children aged 18 months to 16 years requiring surgical pulmonary valve replacement, at 12 U.S. sites. It is a single-arm design — every enrolled child received AUTUS, with no randomized comparison to a conventional bioprosthetic valve — so the results below describe AUTUS’s own performance, not a head-to-head advantage over existing options.

The pivotal trial at a glance

62children enrolled across 12 U.S. sites, ages 18 months to 16 years

100%free of device-related complications through 30 days

0valve reinterventions through 6 months, with consistent results reported at 1 year

≤40 mmHgmean RVOT gradient, with less than moderate pulmonary regurgitation

From Edwards Lifesciences’ FDA approval announcement and the trial registry (NCT05006404). Longer-term durability and catheter-expansion performance data are not yet available; annual follow-up continues through 10 years.

Typically, we give these children a temporary fix, knowing they will need more surgeries down the road. Now, we may be giving a child a valve that could potentially last them a lifetime. undefined

Dr. Romano is not a disinterested observer: she was a site investigator on the pivotal trial, and on 31 August 2026 she performed the first implant of a commercially intended AUTUS valve in the U.S., in a six-year-old patient at C.S. Mott Children’s Hospital, under the Continued Access Study that let select centers use the device while FDA review was underway. A second investigator, Dr. Emile Bacha, surgeon-in-chief at NewYork-Presbyterian/Columbia University Irving Medical Center, framed the approval in planning terms rather than outcomes terms: “The AUTUS valve gives congenital heart teams a new way to think about long-term care planning for pediatric patients who may otherwise face multiple surgeries.”

Where AUTUS sits next to Melody and Harmony

Physicians who already place transcatheter pulmonary valves may reasonably ask how AUTUS relates to Medtronic’s Melody and Harmony valves. The answer is that they occupy different points in a patient’s surgical history rather than competing for the same procedure.

Three pulmonary valve options, three different jobs

	AUTUS (Edwards)	Melody (Medtronic)	Harmony (Medtronic)
Role in care	First valve at the primary surgical repair	Reintervention inside an already-failing RVOT conduit	Reintervention in a native or patched RVOT with regurgitation
Delivery	Surgical implant, then transcatheter balloon expansion in place as the child grows	Transcatheter, deployed inside an existing conduit	Transcatheter, deployed into the native or patched outflow tract
Leaflet material	Polymeric (synthetic) — the first FDA-approved valve of its kind	Bovine jugular vein tissue	Porcine pericardial tissue
U.S. status	Approved 1 October 2026	Approved 2010	Approved 2021
Youngest practical use	As early as 18 months, implanted as small as 13 mm	Typically older children whose earlier conduit is now failing	Typically older children or adolescents whose native RVOT needs treatment

Melody and Harmony particulars from Medtronic’s own product materials and published registry experience; prescribe and plan from current labeling, not this table. A child who already has a conduit or a prior transcatheter valve is not a retrofit candidate for AUTUS.

What the trial can’t yet answer

• Valve durability past 1 year. The pivotal trial’s longest reported outcomes run to 12 months; follow-up continues annually through 10 years, which is closer to the real test for a device meant to serve a child through adolescence.
• How many expansions a frame tolerates. Edwards has not published a maximum expansion count or an expected interval between catheter-based enlargements.
• Whether polymeric leaflets genuinely outlast tissue in this specific application — a plausible mechanism, not yet a demonstrated outcome.
• What happens once a child reaches the 22 mm ceiling. Whether every patient eventually needs surgical replacement once fully grown, or whether 22 mm suffices for most adult-sized RVOTs, is unanswered.
• Long-term valve competence and regurgitation after repeated balloon dilations, which can in principle stress leaflet coaptation differently than a single static implant.

Availability, training and what changes in practice

AUTUS is approved, but availability is narrow for now. The device reached patients during FDA review only through the Continued Access Study’s roughly 12 sites, the same centers that ran the pivotal trial; Edwards has not said how quickly it will expand access beyond them, and has not announced a list price. Two distinct skill sets are involved over a child’s course of care — the congenital heart surgeon who performs the initial implant, using largely familiar surgical technique, and the interventional or congenital cardiologist who later performs the catheter-based expansions, a procedure type that is new to this specific device even for teams experienced with Melody or Harmony. Centers adopting AUTUS should expect a training and credentialing step for the expansion procedure specifically, not just the initial implant.

On reimbursement, the initial surgical implant should be billable under the existing CPT code for pulmonary valve replacement (33475), the same code used for any surgical pulmonary valve, with payment set at the hospital and surgeon level as for any inpatient congenital heart operation. What is not yet established is coding and payer coverage for the later catheter-based expansion procedures — a new procedure type tied to a newly approved device, with no published CPT assignment or payer policy as of this approval. Families and centers should not assume that follow-on expansions will be reimbursed on the same terms as the initial surgery until a specific code and coverage policy exist.

What changes at the surgical planning table

• Candidate selection. Toddlers and young children facing a first pulmonary valve replacement for congenital heart disease are the clearest fit; a child who already has a conduit or a prior transcatheter valve is not a retrofit candidate.
• Referral and counseling. Families can be told, honestly, that one goal of the device is fewer open operations over childhood — not yet a demonstrated reduction in lifetime surgery count, which the trial has not run long enough to show.
• Multidisciplinary coordination. The surgeon who implants and the interventional cardiologist who later expands need a shared plan for monitoring growth and timing expansions, a workflow most congenital heart programs have not needed to build before.
• Site capability. Programs considering AUTUS need both a congenital heart surgery service and a cath lab credentialed for the expansion procedure — not a given at every center that currently performs pediatric pulmonary valve surgery.
• What doesn’t change yet. Melody and Harmony remain the tools for a patient who already has a failing conduit or regurgitant native RVOT; AUTUS does not reach backward into that population.

From first enrollment to FDA approval

1. Feb 2024

   Pivotal trial begins

   The Autus Valve Pivotal Study (NCT05006404) starts enrolling children 18 months to 16 years at 12 U.S. sites.

2. Feb 2026

   Edwards acquires Autus Valve Technologies

   Total consideration of $128.9 million, with up to $132.5 million more tied to regulatory and sales milestones.

3. 31 Aug 2026

   First U.S. commercial-track implant

   Dr. Jennifer Romano implants AUTUS in a six-year-old patient at C.S. Mott Children’s Hospital under the Continued Access Study, while FDA review was still underway.

4. 1 Oct 2026

   FDA approves AUTUS

   The first size-adjustable surgical pulmonary valve, and the first FDA-approved heart valve with synthetic leaflets.

5. Ahead

   10-year follow-up continues

   Annual follow-up on the pivotal cohort, plus catheter-expansion performance data, still to be reported.

Frequently asked questions

Does AUTUS replace Melody or Harmony for transcatheter pulmonary valve replacement?

No. Melody and Harmony are transcatheter valves used to treat a failing conduit or a regurgitant native right ventricular outflow tract after an earlier repair — a reintervention. AUTUS is surgically implanted at the first repair, as early as 18 months of age, and is then widened in place by balloon catheter as the child grows. A child who already has a conduit or a prior transcatheter valve is not a retrofit candidate for AUTUS.

How many times can an AUTUS valve be expanded, and does it ever need surgical replacement?

The pivotal trial has not yet reported how many expansions a valve tolerates over a full childhood, or whether every patient eventually needs surgical replacement once the frame reaches its 22 mm maximum. Follow-up continues annually through 10 years. Until then, a reasonable expectation — not yet a trial finding — is fewer open-heart operations, not necessarily zero.

Is the AUTUS valve available now, and what will it cost?

FDA approved AUTUS on October 1, 2026. Edwards has not announced a commercial price, insurance coverage terms, or which centers beyond the pivotal and continued-access trial sites will offer it first. The surgical placement should be billable under the existing CPT code for pulmonary valve replacement; coding and payer coverage for the later transcatheter expansion procedures have not yet been established.