Medtronic has said that the new European data from five national clinical registries presented at EuroPCR demonstrated encouraging outcomes for more than 2,000 patients treated with its CoreValve percutaneous aortic valve system.
Medtronic added that the data presented during the ‘TAVI Facts, Figures and National Registries’ session included findings from registries in Belgium, France, Germany, Italy and the UK.
Overall the results demonstrated sustained positive patient outcomes following the procedure at six months and, in some studies, at one year.
The new data reaffirm findings from previous clinical trials that demonstrate high procedure success rates and positive clinical outcomes in patients who have received the CoreValve system.
The Italian Registry in particular, with more than 750 patients, provides a deeper look at the performance of CoreValve. There was a significant and long-term improvement in symptoms, including heart failure improvement with a reduction in New York Heart Association (NHYA) functional class in a majority of patients. In addition, all hemodynamic performance indicators improved, and left ventricle hypertrophy (excessive wall thickness) decreased six months after implant.
The CoreValve system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the US. Typically delivered through the femoral artery, CoreValve is used in 75% of transarterial transcatheter valve replacement procedures.
Reportedly, the CoreValve system received Conformite Europeenne (CE) Mark in March 2007. It is not yet available in the US for clinical trial or commercial sale or use.
Eberhard Grube, chief of the division of Structural Heart Disease, International Heart Center Rhein–Ruhr, Essen, Germany, said: “The breadth and results of these post-market evaluations suggest that CoreValve is successfully transitioning into general clinical practice. It also shows that patient outcomes largely transcend physician specialties, countries and clinical settings.”