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Medtronic reports positive performance from real-world CoreValve study
Medtronic has announced the findings of a study demonstrating the positive real-world performance of its CoreValve System.
The transcatheter aortic valve implantation device was trialled in the two-year Advance study, which affirmed the safety, efficacy and sustained valve performance of the self-expanding system.
Low rates of mortality and stroke were associated with the use of CoreValve, which demonstrated exceptional valve performance over the two-year period. Meanwhile, a majority of patients experienced dramatic improvement in symptoms, and overall haemodynamic performance was shown to be strong and stable.
Dr Axel Linke, professor of medicine at Universitat Leipzig Herzzentrum in Leipzig, said: "It's impressive to see that these positive clinical outcomes sustain out to two years, affirming the safety and exceptional performance of the CoreValve System."
Since receiving CE Mark approval in 2007, CoreValve has been implanted in more than 60,000 patients in over 60 countries. It was approved for use in the US among patients considered at extreme risk for surgery earlier this year, although it remains limited to investigational use in other groups.
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