(RTTNews) - Edwards Lifesciences (EW) said it received approval from the U.S. Food and Drug Administration for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent ...

The FDA approved a new version of Edwards Lifesciences’ Sapien 3 transcatheter heart valve—coupling it with a self-expanding, stent-like device that helps reshape a malfunctioning pulmonary valve.

The FDA gave the greenlight to transcatheter pulmonic valve replacement with the Sapien 3 system plus an adaptive pre-stent landing zone, dubbed Alterra, for patients with congenital heart disease.

The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (“TPV”) system with Alterra adaptive prestent is indicated for use in the management of pediatric and adult patients with extreme pulmonary ...

The US Food and Drug Administration (FDA) has approved use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (Sapien 3 with Alterra) for patients with severe pulmonary ...

Edwards Lifesciences Corp. appears to be milking as many indications as possible from its transcatheter heart valve (THV) platform. The FDA just approved the company's Sapien XT valve for pulmonic ...

Edwards Lifesciences is closing out 2021 by nabbing a new approval from FDA. The Irvine, CA-based company said it won the nod for the use of the Edwards Sapien 3 transcatheter valve with the Alterra ...

PARIS -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that one-year data from its European post-approval study of the ...

Irvine-based Edwards Lifesciences Corp.’s Sapien XT replacement transcatheter heart valve gained another approval this month. Edwards said the Food and Drug Administration granted it approval to use ...