FDA approved the Edwards Lifesciences AUTUS valve on October 1, a surgical pulmonary valve for children with congenital heart disease. Surgeons implant it at 13 mm. A transcatheter balloon procedure later widens it to as much as 22 mm as the child grows.
The leaflets are made of polymer rather than animal tissue. FDA said animal tissue hardens and breaks down faster in children, which is why pediatric valve replacements get redone. AUTUS is the first heart valve approved in the US with polymeric leaflets.
The approval study enrolled 62 pediatric patients. All were free of device-related complications at 30 days, with no AUTUS valve reinterventions through six months. At one year every patient held a mean RVOT gradient at or below 40 mmHg and less than moderate pulmonary regurgitation. Follow-up runs 10 years.
AUTUS carried Breakthrough Device designation and came through FDA's Total Product Life Cycle Advisory Program, the first pediatric device to do so. For a small company the pairing is the lesson: TAP front-loads the review conversation on a device whose market cannot absorb a long one.