Irvine-based Edwards Lifesciences received FDA approval for what it says is the first surgical pulmonary valve specifically designed for pediatric patients.
The medical device company’s Autus valve, intended for patients with congenital heart disease and require pulmonary valve replacement, has the ability to expand as a child grows.
Valve expansion is performed through a minimally invasive transcatheter procedure, reducing the need for repeat open-heart surgeries.
Shares in Edwards (NYSE: EW) increased less than 1% to $85.37 and a $49 billion market cap a day following the announcement.