Edwards Lifesciences gains FDA approval for expandable pediatric valve

A pediatric pulmonary valve that can be widened as a child grows won U.S. approval Thursday as Edwards Lifesciences Corporation NYSEEW received FDA authorization for AUTUS in children with congenital pulmonary valve disease.

The Oct. 1 company release says the valve is surgically implanted and can later be expanded through a catheter procedure. The FDA cited a study enrolling 62 children, with valve-performance findings reported for the first 60 at six months.

Edwards is a global structural heart device maker whose portfolio includes implanted valves and catheter-delivered heart treatments.

Edwards shares NYSEEW finished lower at US$85.19 at the 4:00:04 p.m. EDT close on Thursday in New York. Edwards gave no launch date in its release, while study participants are to remain in follow-up for 10 years.

The FDA Cited Early Performance and Longer-Term Risks

The valve is implanted at a diameter as small as approximately 13 millimetres and can be widened to 22 millimetres, according to the FDA. Its synthetic leaflets are the first made of polymeric material in an FDA-approved heart valve, replacing the animal-derived tissue used in conventional designs.

The FDA said the first 60 patients showed acceptable blood-flow performance and no more than mild pulmonary leakage at six months. Its account did not present a comparison with an existing valve, so the early data cannot establish how many repeat operations AUTUS will prevent.

The FDA said all study patients had successful implant procedures, with no deaths, strokes, blood clots requiring treatment or other clot-related complications. Three had valve-frame fractures and two had reduced movement of a leaflet, though none of those findings caused symptoms. Two valves were expanded after their recipients began to outgrow them, but the agency said experience with that procedure remains limited.

Edwards reported that all patients were free of device-related complications through 30 days. It also said every patient completing one-year follow-up met its combined valve-performance measures, including no valve reinterventions, but its release did not state how many patients reached that visit.

“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,” said Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, in the agency's Oct. 1 statement.

The agency approved AUTUS through the premarket approval pathway for higher-risk medical devices, following an earlier Breakthrough Device designation. Approval establishes a U.S. marketing pathway; neither the FDA notice nor Edwards' release gave a sales forecast or a date when hospitals could order the valve.

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Medtronic's Pulmonary Conduit Offers a Peer Comparison

Medtronic plc NYSEMDT lists its Contegra pulmonary valved conduit for pulmonary replacement and reconstruction. Edwards' distinguishing claim is that AUTUS can be expanded after implantation by balloon catheter; the FDA's summary does not compare the two devices in a trial.

The U.S. Centers for Disease Control and Prevention estimates that pulmonary valve atresia and stenosis together affect about 4,200 U.S. babies each year, according to the FDA's Oct. 1 announcement. That figure describes congenital disease, rather than the number of children who will need a surgical replacement, and Edwards did not give an addressable-market estimate.

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The Edwards study schedule calls for checks at 30 days and six months before annual follow-up through 10 years. The Oct. 1 release gives no date for another AUTUS report, leaving longer-term valve performance and experience with catheter expansion to be reported later.