Edwards Sapien XT valve granted FDA approval for aortic valve-in-valve procedures


Edwards Lifesciences has announced US FDA approval has been granted for aortic valve-in-valve procedures using its Sapien XT transcatheter heart valve. This follows the presentation of high survival and low stroke rates from the one-year outcomes of the PARTNER II Valve-in-Valve Study.

One-year patient outcomes for patients treated with transcatheter Sapien XT valve implantation in surgical tissue valves were presented at the 27th Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco. The valve-in-valve procedure was associated with a high overall one-year survival rate of 86.6% and a low overall stroke rate of 3.7% in a very high-risk patient population, according to independently adjudicated data from the 197-patient PARTNER II Valve-in-Valve study. The study, which is a multicentre, non-randomised cohort of The PARTNER II Trial, included 97 patients enrolled in the primary registry as well as 100 continued access patients.

“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,” says Danny Dvir, interventional cardiologist at the Center for Heart Valve Innovation at St. Paul’s Hospital, Vancouver, who presented the data. “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.”

The Edwards Sapien XT valve was approved by the FDA in June 2014 for patients at high risk for native aortic valve replacement surgery, and received CE mark for valve-in-valve procedures in early 2014. The Sapien valve platform has been used in the treatment of more than 100,000 patients worldwide.