European Registries Confirm Benefits of Medtronic's CoreValve System

May 25, 2010—Medtronic, Inc. (Minneapolis, MN) announced that new European data from five national clinical registries studying transcatheter aortic valve implantation (TAVI) were presented at the EuroPCR 2010 conference in Paris. The reported results demonstrated positive clinical outcomes in more than 2,000 severe aortic stenosis patients treated with the company's CoreValve percutaneous aortic valve system.
 

“We welcome the abundance of positive data, which show that transcatheter aortic valve therapy is a successful treatment option for a patient population who is at high risk or is unable to undergo surgical valve replacement,” commented Eberhard Grube, MD. “The breadth and results of these postmarket 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.”



According to the company, data presented during the “TAVI Facts, Figures, and National Registries” session included findings from registries in Belgium, France, Germany, Italy, and the United Kingdom. Overall, the results demonstrate sustained positive patient outcomes following the procedure at 6 months and at 1 year. These 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 company noted that the Italian Registry in particular, with more than 750 patients, provides a deeper look at the performance of CoreValve. There was a highly significant and long-term improvement in symptoms, including heart failure improvement, with a reduction in New York Heart Association functional class in a majority of patients. In addition, all hemodynamic performance indicators improved, and left ventricle hypertrophy decreased 6 months after implantation. The CoreValve system received CE Mark approval in March 2007; however, it is not yet available for clinical trial use or for commercial sale in the United States.

“The overall results of the Italian Registry were quite impressive, indicating superb device performance and patient outcomes, as well as relatively low complication rates,” commented Sonia Petronio, MD. “We were especially pleased to see an early reduction in left ventricular hypertrophy similar to what is seen with surgical aortic valve replacement. These results suggest that CoreValve is not only a suitable aortic replacement valve but may also improve the overall pumping function of the heart.”