Edwards Sapien XT valve granted expanded FDA approval for pulmonic procedures



The US Food and Drug Administration (FDA) has approved the Sapien XT transcatheter heart valve (Edwards Lifesciences) for an expanded indication relating to pulmonic valve replacement procedures.

Adult and paediatric patients presenting with either a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease are now approved for treatment by the Sapien XT valve.

“US approval of the SAPIEN XT valve for pulmonic procedures provides an important, minimally invasive treatment option for a small group of patients who typically face the burden of multiple open-heart surgeries, oftentimes beginning at birth or during childhood.” says Larry L Wood, Edwards’ corporate vice president, transcatheter heart valves.

According to a company release, FDA approval of the Edwards SAPIEN XT valve for pulmonic procedures was supported by data from the multicentre COMPASSION clinical trial, and additional clinical data from Europe.