Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, announced that a U.S. Food and Drug Administration (FDA) Advisory Panel voted late today to recommend approval of the Edwards SAPIEN transcatheter heart valve for the treatment of certain inoperable patients.
Edwards submitted a PMA application in the fall of 2010 based on data from the inoperable cohort of The PARTNER Trial. This cohort compared the outcomes of 358 patients after treatment with either standard therapy or the Edwards SAPIEN valve delivered transfemorally.
"We are pleased with the panel’s strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from The PARTNER Trial. This represents another important step on the path to what we hope will lead to FDA approval of SAPIEN," said Michael A. Mussallem, Edwards’ chairman and CEO. "We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy."
The Edwards SAPIEN valve is an investigational device in the U.S. and not yet available commercially in the U.S. It received CE Mark approval for European commercial sale in late 2007.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.