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FDA premarket approval · Edwards Lifesciences · Pediatrics

Autus Size-Adjustable Valve

FDA approves the first pulmonary heart valve that can be expanded as a child grows.

CompareFDA press release
Approved · PMABreakthrough device

Autus Size-Adjustable Valve

Edwards Lifesciences · Pediatrics · First expandable pediatric heart valve

Type
Implant
FDA route
Premarket approval (PMA)
Bottom line for your practice
55s read

Children who need a pulmonary valve replacement now have a surgical valve that can be enlarged by balloon catheter as they grow, which the FDA says may reduce the need for repeat open-heart surgeries. Data on expansion are limited and longer-term studies are under way.

What it is
A surgically implanted pulmonary heart valve with polymeric leaflets instead of animal-derived tissue. It can be implanted as small as approximately 13 millimeters in diameter and later widened with a balloon catheter, up to 22 millimeters.
Indicated for
Pediatric patients with congenital pulmonary valve disease who need pulmonary valve replacement.
What changes
The FDA says traditional valves use animal-derived tissue, which tends to harden and break down faster in children and often requires earlier repeat surgery. The release does not describe the design of the clinical study.
Evidence
Design not reportedStudy not named in the release · n=62At the six-month follow-up, the first 60 patients demonstrated acceptable hemodynamic performance with no more than mild leakage back through the valve. All patients had a successful procedure, with no deaths, blood clots requiring additional treatment, strokes or other clot-related complications.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
Three patients had a fracture in the valve frame and two had reduced movement of one valve leaflet, none with symptoms. Valve performance began deteriorating in two patients who started to outgrow it; both were expanded successfully, but the FDA says the experience is limited and longer-term studies are being conducted.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.Breakthrough Device designation: for devices that may offer more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. It speeds the FDA's interaction and review. It does not lower the standard for authorization.

Clinical summary

The Autus Size-Adjustable Valve is a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease; it can be widened later with a balloon catheter. Approval rests on a clinical study of 62 pediatric patients at 12 U.S. sites, in which the first 60 patients showed acceptable hemodynamic performance at six months with no more than mild leakage. Three patients had a valve frame fracture, two had reduced leaflet movement, and experience with expansion is limited to two patients.

From the source 14

FDA press release

The FDA press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.

    Backs · Date 2026-10-01 is the FDA decision date (release dated October 01, 2026 says 'today approved')

  2. The Autus Size-Adjustable Valve is the first heart valve designed to be expanded after surgery to keep pace with a child’s growth, and the first valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its inner flaps (called leaflets).

    Backs · First claim: first valve designed to be expanded after surgery; first with polymeric leaflets

  3. The Autus Size-Adjustable Valve can be initially implanted as small as approximately 13 millimeters in diameter — the right size for a toddler or preschool-aged child — and later widened using a small inflatable tube (balloon catheter) as the child grows, eventually reaching up to 22 millimeters, which is comparable to an adult-sized pulmonary valve.

    Backs · Approximately 13 millimeters at implant, up to 22 millimeters after balloon expansion

View all 14 lines

  1. The FDA’s approval is based on data from a clinical study, which enrolled 62 pediatric patients across 12 U.S. sites.

    Backs · 62 pediatric patients, 12 U.S. sites

  2. At the six-month follow-up, the first 60 patients demonstrated acceptable hemodynamic performance, meaning blood flow through the right side of the heart was within acceptable limits, and there was no more than mild leakage back through the valve.

    Backs · First 60 patients at six months: acceptable hemodynamic performance, no more than mild leakage

  3. All patients in the study had a successful procedure, with no deaths, blood clots requiring additional treatment, strokes or other clot-related complications.

    Backs · All procedures successful; no deaths, clots needing treatment or strokes

  4. Three patients experienced a fracture in the valve frame and two patients had reduced movement of one of the valve leaflets (the flaps that open and close), but none of these events resulted in symptoms for the patients.

    Backs · Three frame fractures, two reduced leaflet movement, none symptomatic

  5. Additionally, valve performance began deteriorating in two patients who started to outgrow it. Both patients had their valves successfully expanded without an invasive surgical procedure, but the experience is limited.

    Backs · Two patients outgrew the valve and had it expanded; experience limited

  6. One-year follow-up data suggest the Autus valve’s synthetic leaflets hold up well over time.

    Backs · One-year follow-up on leaflets

  7. Traditional valves use tissue derived from animals, which tends to harden and break down faster in children, often requiring earlier repeat surgery.

    Backs · Animal tissue valves break down faster in children

  8. The FDA previously granted the Autus Size-Adjustable Valve Breakthrough Device designation, which is meant to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

    Backs · Breakthrough Device designation

  9. The Autus Size-Adjustable Valve was approved through the premarket approval pathway, the FDA’s most stringent type of medical device marketing application. The pathway is used for certain Class III devices, which generally pose the greatest risk.

    Backs · Pathway PMA; Class III

  10. Edwards Lifesciences received approval for the Autus Size-Adjustable Valve, developed by Autus Valve Technologies Inc.

    Backs · Company: Edwards Lifesciences

  11. The Autus Size-Adjustable Valve gives doctors the option of far fewer trips to the operating room, which may result in better quality of life for these children and their families.

    Backs · Setting: operating room

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