Edwards Sapien XT Valve Receives FDA Approval for Valve-in-Valve Procedures; Data Presented at TCT

October 15, 2015—Edwards Lifesciences Corporation announced it has received US Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards Sapien XT transcatheter aortic valve replacement (TAVR) system. The FDA approved the Edwards Sapien XT valve in June 2014 for patients at high risk for native aortic valve replacement surgery. The device received European CE Mark approval for valve-in-valve procedures in early 2014.

The company also announced that 1-year patient outcomes were presented for patients treated with the Sapien XT device implantation in surgical tissue valves at TCT 2015, the 27th Transcatheter Cardiovascular Therapeutics of the Cardiovascular Research Foundation being held October 11–15, in San Francisco, California. The data were presented by Danny Dvir, MD, an interventional cardiologist at the Center for Heart Valve Innovation at St. Paul’s Hospital in Vancouver, British Columbia.

According to the company, the valve-in-valve procedure was associated with a high overall 1-year survival rate of 86.6% and a low overall stroke rate of 3.7% in a very high-risk patient population. The independently adjudicated data are from the 197-patient PARTNER II Valve-in-Valve study, which is a multicenter, nonrandomized cohort of the PARTNER II trial, included 97 patients enrolled in the primary registry as well as 100 continued-access patients.

In Edwards’ press release, Dr. Dvir commented, “We were very pleased to see 100% survival at 30 days with the 100 high-risk patients treated with the Sapien XT valve-in-valve procedure in the continued access registry. This is quite remarkable and supports transcatheter aortic valve-in-valve replacement with the Sapien XT valve as a safe therapeutic alternative to reoperation for patients in need of a subsequent tissue valve replacement.”