FDA Panel to Review Edwards Sapien Valve on July 20

June 7, 2011—Edwards Lifesciences Corporation (Irvine, CA) announced that a US Food and Drug Administration (FDA) Advisory Panel is scheduled to review the company's premarket approval (PMA) application for the Edwards Sapien transcatheter heart valve on July 20, 2011. In the United States, the Sapien valve is an investigational device and is not yet commercially available, the company advised.

According to Edwards, the PMA application was submitted in the fall of 2010 for approval of this therapy in the treatment of inoperable patients with severe aortic stenosis. The application was based on data from the inoperable cohort (cohort B) of the PARTNER trial. The inoperable cohort compared outcomes after treatment with either standard therapy or the Edwards Sapien valve in 358 patients. In September 2010, as reported in Cardiac Interventions Today, Martin B. Leon, MD, et al published the cohort B data in The New England Journal of Medicine (2010;363:1597–1607).

On June 6, the company also announced the first implants in China of the Edwards Sapien XT valve. The transfemoral valve implantations were successfully performed in May as special access cases under a joint educational and training program on transcatheter aortic valve replacement between the Second Military Medical University and Edwards. The company noted that the Edwards Sapien XT valve was approved for sale in Europe in March 2010. It is an investigational device in the United States, Japan, and China.