TAVR Market Heats Up As Medtronic’s CoreValve Wins Early FDA Approval
Executive Summary
Medtronic Inc.’s CoreValve transcatheter aortic valve replacement (TAVR) device won FDA approval in January, months earlier than anticipated, setting the stage for a competitive battle in the US between Medtronic and market leader Edwards Lifesciences Corp. According to Jeffrey Popma, MD, the early approval can be attributed not only to the excellent design and execution of the CoreValve pivotal trial, but also to the new, more collaborative environment that is emerging at the US Food and Drug Administration.