Documentary record · October 19, 2026 edition
Autus Size-Adjustable Valve — first heart valve designed to be expanded as a child grows
APPROVED. Long-term studies are ongoing.
SOURCE-VERIFIED · HUMAN REVIEW PENDING
Event date
October 1, 2026
Lifecycle state
APPROVED. Long-term studies are ongoing.
Source published
October 1, 2026
Source checked
October 19, 2026
Published on KPSGILL
- Approval: October 1, 2026, PMA, Class III (Edwards Lifesciences). Prior designations: Breakthrough Device; first pediatric approval through FDA's TAP program.
- Device: polymeric leaflets, implanted at about 13 mm and balloon-expandable to 22 mm.
- Study: 62 children at 12 U.S. sites.
- Complications reported: 3 valve-frame fractures and 2 cases of reduced leaflet motion, none symptomatic.
- Status: APPROVED. Long-term studies are ongoing.
- Not established: long-term durability. Post-implant expansion has been performed in only two patients; FDA calls that experience "limited".
Sources
- FDA press release Autus valve Primary · 2026-10-01 · checked 2026-10-19
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