Edwards AUTUS Valve Wins FDA Approval for Children

Edwards Lifesciences has received FDA approval for the AUTUS Size Adjustable Valve, a surgical pulmonary valve for children with congenital pulmonary valve disease who need valve replacement. The valve can be expanded after implantation as a child grows, potentially giving some patients an alternative to repeated open-heart surgery.

The valve can initially be inserted with a diameter of about 13 millimetres and later expanded to a maximum of 22 millimetres using a balloon catheter, so the implanted valve can accommodate changes in achild’ss anatomy as they grow.

A different approach to pediatric valve replacement

Children who need a pulmonary valve replacement may eventually outgrow the valve originally fitted to them and will then probably need another operation to replace it with a larger one.

AUTUS takes a different approach. Instead of removing the existing valve, doctors can expand it through a catheter procedure when it needs to grow. The FDA says the device is the first heart valve approved in the United States that can be expanded after surgery to keep pace with a child’s growth.

The valve also uses polymeric material for its leaflets, the parts that open and close to control blood flow. The FDA says AUTUS is the first valve it has approved using polymeric leaflet material for any indication, rather than animal-derived tissue.

According to Edwards Lifesciences, the valve was developed specifically for pediatric patients who require surgical pulmonary valve replacement. The company says its ability to expand as children grow could reduce the need for repeat open heart procedures, although the longer-term effect remains to be established.

Clinical evidence behind the approval

The FDA approval was based on a key study involving 62 pediatric patients across 12 U.S. sites. At six months, the first 60 patients had acceptable blood flow through the right side of the heart and no more than mild leakage through the pulmonary valve.

All patients in the study had a successful procedure, with no deaths, strokes or blood clots requiring additional treatment reported in the FDA’s review. Three patients experienced a fracture of the valve frame, while two had reduced movement of one leaflet. None of those events caused symptoms.

The study also offered an early look at whether the valve could actually be adjusted after implantation. Two patients began to outgrow their valves, and both were successfully treated by expanding the valves without another invasive surgical procedure. The FDA noted that this experience is still limited and that longer follow-up is needed.

Edwards reported that patients who completed one year of follow-up continued to show favourable valve performance. The company said all of those patients had a right ventricular outflow tract mean gradient of 40 mmHg or less, less than moderate pulmonary regurgitation and no valve reinterventions.

Long-term follow-up will be important.

The early results support the idea behind an adjustable pediatric pulmonary valve, but they do not yet show how AUTUS will perform throughout childhood. Durability, valve performance after expansion and whether the design actually reduces the number of major procedures will require longer follow-up.

The AUTUS clinical study monitors patients for 10 years after implantation. Patients who undergo valve expansion receive additional follow-up after the procedure, giving researchers a longer view of how the valve performs as children grow.

The FDA approved AUTUS through its premarket approval pathway and had previously granted the device Breakthrough Device designation. For pediatric cardiac teams, the main significance of the approval is the option to adjust the implanted valve later rather than treating growth as an automatic reason for another valve replacement operation.