Edwards Secures FDA Approval For First Adjustable Pulmonary Valve For Children

(RTTNews) - Edwards Lifesciences (EW) announced that the U.S. FDA has approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed for pediatric patients with congenital heart disease who require pulmonary valve replacement.

Children born with congenital heart disease often require pulmonary valve replacement at a young age. Because children continue to grow, many patients need multiple open-heart surgeries over their lifetime to replace valves that become too small.

According to the company, the AUTUS value is the first FDA-approved surgical pulmonary valve specifically designed for pediatric anatomy with the ability to be expanded as a child grows. The valve can later be enlarged through a minimally invasive transcatheter procedure, potentially reducing the need for repeat surgeries.

The FDA approval was based on results from a pivotal study evaluating the safety and effectiveness of the device. The study met its primary safety and effectiveness endpoints, with 100% of patients free from device-related complications through 30 days and no AUTUS valve reinterventions through six months.

Among patients who completed one-year follow-up, 100% demonstrated favorable outcomes, including acceptable valve performance, less than moderate pulmonary regurgitation and no valve reinterventions. Patients will continue to be followed for 10 years.

The AUTUS valve previously received FDA Breakthrough Device designation, reflecting its potential to address an important unmet need in pediatirc heart care. The approval expands Edwards' portfolio of therapies for patients with congenital heart disease, which also includes the SAPIEN 3 valve system and the Alterra Adaptive Prestent.

Upcoming Milestones

Patients enrolled in the pivotal study will continue to be monitored for up to 10 years to evaluate long-term safety and valve performance.

The FDA approval marks a significant milestone for Edwards as it expands its congenital heart disease franchise into pediatric surgical valve replacement.

EW has traded between $72.30 and $96.29 over the past year. The stock closed Thursday's trading at $85.19, down 1.31%. In overnight trading the stock is at $85.93, up 0.87%.