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The Source serial registry reported results on 1,038 patients, or 100% of patients treated with the Edwards Sapien valve at 32 European commercial centers from November 2007 to January 2009.
According to Edwards Lifesciences, the data showed a 30-day survival rate of 93.7% in transfemoral procedures, and 89.7% in transapical procedures - rates that were better than the predicted surgical survival in this high-risk patient cohort. Implant procedure safety with the Edwards Sapien valve was strongly demonstrated with low incidences of valve malposition (1.5%), coronary obstruction (0.6%), stroke (2.5%), conversion to surgery (2.7%), need for permanent pacemaker (7%), and significant aortic regurgitation (4.7%).
The company has also reported the first complete six-month data set of the 130 patients enrolled in the Partner EU clinical trial. The data demonstrated strong hemodynamics and valve performance through measurements including effective orifice area and ejection fraction, as well as 100% freedom from structural valve deterioration.
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.
Michael Mussallem, chairman and CEO of Edwards Lifesciences, said: "We are very proud of the robust clinical results presented today at EuroPCR, and the rigorous scientific approach we have taken in the study of this transcatheter valve. 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."
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