Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the U.S. Food and Drug Administration (FDA) conditionally approved the addition of a second treatment group to The PARTNER II Trial, which is studying the company’s next-generation Edwards SAPIEN XT transcatheter heart valve.
“Based on the favorable outcomes in The PARTNER Trial, we are pleased to be able to study our next-generation valve platform in an expanded patient population that can benefit from a less-invasive therapy,”
This new cohort (Cohort A) of The PARTNER II Trial is a non-inferiority study of up to 2,000 patients with severe, symptomatic aortic valve stenosis who have an elevated risk for traditional open-heart surgery (Society of Thoracic Surgeons score >4), which is a lower risk profile than those who were enrolled in The PARTNER Trial. Patients will be evenly randomized to receive the Edwards SAPIEN XT valve or surgery. Those undergoing transcatheter valve replacement will be treated either transfemorally (via the femoral artery) or transapically (via a small incision between the ribs). The primary endpoint to be evaluated is a composite of death and major stroke at two years, with secondary endpoints that include valve performance and quality-of-life indicators.
“Based on the favorable outcomes in The PARTNER Trial, we are pleased to be able to study our next-generation valve platform in an expanded patient population that can benefit from a less-invasive therapy,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter valve replacement. “The success of this trial would support the use of the transcatheter therapy in a broader group of patients.”
Edwards hopes to complete enrollment in the first cohort (Cohort B) of this trial around year-end. Data from this cohort of inoperable patients is intended to support U.S. commercial approval of the Edwards SAPIEN XT valve.
The Edwards SAPIEN XT valve is commercially available in Europe, where it received a CE Mark in March 2010. The Edwards SAPIEN XT transcatheter valve is an investigational device in the U.S. and is not yet available commercially.
Source: Edwards Lifesciences Corporation