According to a securities filing, before the acquisition, Edwards paid $11.5 million for the option to buy Autus. The valve can be implanted at about 13 millimetres in diametre to fit a toddler or preschool-age child and widened to reach 22 millimetres, which is comparable to an adult pulmonary valve, said the US Food and Drug Administration (FDA). FDA Centre for Devices and Radiological Health director, Michelle Tarver said the Autus valve could mean fewer trips to the operating room for children who need pulmonary valve replacement. “For children born with congenital heart disease, valve replacement timing has always been a difficult decision — wait too long and you risk harm to the child, but intervene too early and they may need multiple open-heart surgeries as they grow,” Tarver said in a statement.
Edwards said FDA premarket approval was based on clinical evidence from a pivotal study that met its primary safety and effectiveness endpoints. The study enrolled 62 children across 12 US sites. The FDA said at six months, the first 60 patients demonstrated blood flow through the right side of the heart that was within acceptable limits, and there was no more than mild leakage back through the valve. All patients in the study had a successful procedure. Three patients experienced a fracture in the valve frame, and two patients had reduced movement of one of the valve leaflets, but none of the events resulted in symptoms. In addition, the agency said, valve performance began deteriorating in two patients who started to outgrow it.
Both had their valves successfully expanded without an invasive surgical procedure. One-year follow-up data suggest the valve’s synthetic leaflets hold up well over time, the FDA said. Patients in the study will continue to be followed for 10 years, Edwards said. The Autus valve previously received FDA breakthrough device designation, which is intended to expedite development and review. The device is the first pediatric approval to come out of the FDA’s total product life cycle advisory program, also meant to help speed development of innovative medical devices. Edwards said the approval of Autus expands treatment options for congenital disease that also include the Sapien 3 valve, Alterra Adaptive Present and pediatric atrioseptostomy catheters.
