Edwards Lifesciences Corporation announced the results from its first post-market study of consecutively enrolled Edwards SAPIEN transcatheter aortic valve patients at the EuroPCR 2009 conference in Barcelona.
The data demonstrated the successful commercialization of the Edwards SAPIEN valve with high device success and low 30-day mortality.
The study included 1,038 patients, or 100 percent of patients treated with the Edwards SAPIEN valve at 32 European commercial centers from November 2007 to January 2009. The data showed a 30-day survival rate of 93.7 percent in transfemoral procedures (valve delivered via the femoral artery), and 89.7 percent in transapical procedures (valve delivered via a small incision between the ribs), rates that were better than the predicted surgical survival in this high-risk patient cohort.
Implant procedure safety with the SAPIEN valve was strongly demonstrated with low incidences of valve malposition (1.5 percent), coronary obstruction (0.6 percent), stroke (2.5 percent), conversion to surgery (2.7 percent), need for permanent pacemaker (7 percent), and significant aortic regurgitation (4.7 percent).
Also presented was the first complete six-month data set of the 130 patients enrolled in the PARTNER EU clinical trial. PARTNER EU was designed to evaluate the Edwards SAPIEN valve in a setting where, for the first time, an interventional cardiologist and cardiac surgeon partnered to screen and determine the correct treatment approach for each patient.
The data demonstrated strong hemodynamics and valve performance through measurements including effective orifice area and ejection fraction, as well as 100 percent freedom from structural valve deterioration. The study was conducted in Europe from April 2007 through January 2008.
"We are very proud of the robust clinical results presented at EuroPCR, and the rigorous scientific approach we have taken in the study of this transcatheter valve," said Michael A. Mussallem, Edwards' chairman and CEO. "In particular, the 30-day results for the initial commercial experience with the Edwards SAPIEN valve validate the effectiveness of the valve and its two delivery options, as well as the strength of the physician partnership approach."
The Edwards SAPIEN valve is approved for commercial sale in Europe. In the United States, it is an investigational device being studied as part of the PARTNER Trial, the world's only randomized controlled clinical trial of a transcatheter aortic heart valve to date.
Sources: Edwards Lifesciences and Marketwire